LATEX FOLEY
This device is manufactured by CR BARD (COVINGTON) -1018233.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Tissue Injury | 1 | Patient |
| 2024 | Unspecified Infection | 1 | Patient |
| 2024 | Swelling/ Edema | 1 | Patient |
| 2024 | Pain | 1 | Patient |
| 2024 | Hypersensitivity/Allergic reaction | 1 | Patient |
| 2024 | Foreign Body In Patient | 2 | Patient |
| 2024 | Discomfort | 1 | Patient |
| 2024 | Appropriate Term / Code Not Available | 5 | Patient |
| 2024 | Partial Blockage | 4 | Device |
| 2024 | Naturally Worn | 1 | Device |
| 2024 | Missing Information | 1 | Device |
| 2024 | Material Too Rigid or Stiff | 1 | Device |
| 2024 | Material Split, Cut or Torn | 4 | Device |
| 2024 | Material Rupture | 8 | Device |
| 2024 | Material Puncture/Hole | 9 | Device |
| 2024 | Material Fragmentation | 2 | Device |
| 2024 | Inflation Problem | 1 | Device |
| 2024 | Incorrect Measurement | 1 | Device |
| 2024 | Inaccurate Flow Rate | 2 | Device |
| 2024 | Inability to Irrigate | 1 | Device |
| 2024 | Fracture | 1 | Device |
| 2024 | Fluid/Blood Leak | 4 | Device |
| 2024 | Failure to Infuse | 3 | Device |
| 2024 | Difficult to Remove | 4 | Device |
| 2024 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2024 | Deformation Due to Compressive Stress | 1 | Device |
| 2024 | Decrease in Pressure | 1 | Device |
| 2024 | Burst Container or Vessel | 12 | Device |
| 2023 | Urinary Tract Infection | 1 | Patient |
| 2023 | Tissue Breakdown | 1 | Patient |
| 2023 | Swelling/ Edema | 1 | Patient |
| 2023 | Pain | 2 | Patient |
| 2023 | Hematuria | 1 | Patient |
| 2023 | Hematoma | 1 | Patient |
| 2023 | Foreign Body In Patient | 1 | Patient |
| 2023 | Failure of Implant | 1 | Patient |
| 2023 | Appropriate Term / Code Not Available | 10 | Patient |
| 2023 | Solder Joint Fracture | 1 | Device |
| 2023 | Patient Device Interaction Problem | 1 | Device |
| 2023 | No Flow | 1 | Device |
| 2023 | Material Twisted/Bent | 3 | Device |
| 2023 | Material Split, Cut or Torn | 7 | Device |
| 2023 | Material Rupture | 2 | Device |
| 2023 | Material Puncture/Hole | 12 | Device |
| 2023 | Material Integrity Problem | 1 | Device |
| 2023 | Material Fragmentation | 4 | Device |
| 2023 | Incorrect Measurement | 2 | Device |
| 2023 | Inaccurate Flow Rate | 1 | Device |
| 2023 | Fluid/Blood Leak | 17 | Device |
| 2023 | Failure to Infuse | 14 | Device |
| 2023 | Disconnection | 1 | Device |
| 2023 | Difficult to Remove | 5 | Device |
| 2023 | Device Contamination with Chemical or Other Material | 2 | Device |
| 2023 | Dent in Material | 3 | Device |
| 2023 | Deformation Due to Compressive Stress | 4 | Device |
| 2023 | Deflation Problem | 2 | Device |
| 2023 | Decrease in Pressure | 8 | Device |
| 2023 | Component Misassembled | 1 | Device |
| 2023 | Burst Container or Vessel | 21 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2022 | Appropriate Term / Code Not Available | 1 | Patient |
| 2022 | Use of Device Problem | 1 | Device |
| 2022 | Physical Resistance/Sticking | 1 | Device |
| 2022 | Migration | 1 | Device |
| 2022 | Material Split, Cut or Torn | 3 | Device |
| 2022 | Material Puncture/Hole | 13 | Device |
| 2022 | Material Protrusion/Extrusion | 1 | Device |
| 2022 | Material Invagination | 1 | Device |
| 2022 | Material Fragmentation | 5 | Device |
| 2022 | Inaccurate Flow Rate | 1 | Device |
| 2022 | Fracture | 4 | Device |
| 2022 | Fluid/Blood Leak | 37 | Device |
| 2022 | Failure to Infuse | 25 | Device |
| 2022 | Disconnection | 2 | Device |
| 2022 | Difficult to Remove | 6 | Device |
| 2022 | Device Handling Problem | 1 | Device |
| 2022 | Deflation Problem | 1 | Device |
| 2022 | Decrease in Pressure | 25 | Device |
| 2022 | Burst Container or Vessel | 9 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2019 | Use of Device Problem | 3 | Device |
| 2019 | Unsealed Device Packaging | 1 | Device |
| 2019 | Tear, Rip or Hole in Device Packaging | 1 | Device |
| 2019 | Structural Problem | 1 | Device |
| 2019 | Restricted Flow rate | 1 | Device |
| 2019 | Positioning Problem | 1 | Device |
| 2019 | Physical Resistance/Sticking | 2 | Device |
| 2019 | Peeled/Delaminated | 1 | Device |
| 2019 | Partial Blockage | 15 | Device |
| 2019 | Obstruction of Flow | 13 | Device |
| 2019 | No Flow | 8 | Device |
| 2019 | Misassembled | 1 | Device |
| 2019 | Migration or Expulsion of Device | 1 | Device |
| 2019 | Material Twisted/Bent | 6 | Device |
| 2019 | Material Too Rigid or Stiff | 1 | Device |
| 2019 | Material Split, Cut or Torn | 1 | Device |
| 2019 | Material Rupture | 11 | Device |
| 2019 | Material Puncture/Hole | 7 | Device |
| 2019 | Material Fragmentation | 2 | Device |
| 2019 | Material Discolored | 2 | Device |
| 2019 | Material Deformation | 7 | Device |
| 2019 | Leak/Splash | 21 | Device |
| 2019 | Labelling, Instructions for Use or Training Problem | 1 | Device |
| 2019 | Insufficient Flow or Under Infusion | 1 | Device |
| 2019 | Infusion or Flow Problem | 2 | Device |
| 2019 | Inflation Problem | 61 | Device |
| 2019 | Inaccurate Flow Rate | 14 | Device |
| 2019 | Inability to Irrigate | 1 | Device |
| 2019 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2019 | Gel Leak | 1 | Device |
| 2019 | Fluid/Blood Leak | 54 | Device |
| 2019 | Filling Problem | 1 | Device |
| 2019 | Failure to Infuse | 66 | Device |
| 2019 | Failure to Align | 1 | Device |
| 2019 | Entrapment of Device | 2 | Device |
| 2019 | Disconnection | 7 | Device |
| 2019 | Difficult to Remove | 25 | Device |
| 2019 | Difficult to Insert | 1 | Device |
| 2019 | Device Slipped | 2 | Device |
| 2019 | Device Markings/Labelling Problem | 2 | Device |
| 2019 | Device Fell | 23 | Device |
| 2019 | Device Emits Odor | 1 | Device |
| 2019 | Device Dislodged or Dislocated | 18 | Device |
| 2019 | Device Damaged Prior to Use | 5 | Device |
| 2019 | Device Contamination with Chemical or Other Material | 3 | Device |
| 2019 | Detachment of Device or Device Component | 12 | Device |
| 2019 | Dent in Material | 3 | Device |
| 2019 | Degraded | 1 | Device |
| 2019 | Deformation Due to Compressive Stress | 7 | Device |
| 2019 | Deflation Problem | 113 | Device |
| 2019 | Crack | 3 | Device |
| 2019 | Contamination /Decontamination Problem | 1 | Device |
| 2019 | Component Missing | 1 | Device |
| 2019 | Complete Blockage | 4 | Device |
| 2019 | Burst Container or Vessel | 24 | Device |
| 2019 | Break | 50 | Device |
| 2019 | Blocked Connection | 1 | Device |
| 2018 | Torn Material | 1 | Device |
| 2018 | Tear, Rip or Hole in Device Packaging | 1 | Device |
| 2018 | Scratched Material | 1 | Device |
| 2018 | Restricted Flow rate | 3 | Device |
| 2018 | Physical Resistance/Sticking | 1 | Device |
| 2018 | Physical Resistance | 2 | Device |
| 2018 | Patient-Device Incompatibility | 3 | Device |
| 2018 | Partial Blockage | 3 | Device |
| 2018 | Packaging Problem | 1 | Device |
| 2018 | Occlusion Within Device | 2 | Device |
| 2018 | Obstruction of Flow | 1 | Device |
| 2018 | Nonstandard Device | 1 | Device |
| 2018 | No Flow | 16 | Device |
| 2018 | Melted | 1 | Device |
| 2018 | Material Twisted/Bent | 4 | Device |
| 2018 | Material Split, Cut or Torn | 5 | Device |
| 2018 | Material Separation | 1 | Device |
| 2018 | Material Rupture | 12 | Device |
| 2018 | Material Puncture/Hole | 4 | Device |
| 2018 | Material Integrity Problem | 3 | Device |
| 2018 | Material Fragmentation | 2 | Device |
| 2018 | Material Deformation | 4 | Device |
| 2018 | Leak/Splash | 17 | Device |
| 2018 | Knotted | 1 | Device |
| 2018 | Kinked | 1 | Device |
| 2018 | Infusion or Flow Problem | 2 | Device |
| 2018 | Inflation Problem | 58 | Device |
| 2018 | Incorrect Measurement | 2 | Device |
| 2018 | Inadequate Instructions for Healthcare Professional | 2 | Device |
| 2018 | Inaccurate Flow Rate | 13 | Device |
| 2018 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2018 | Improper Flow or Infusion | 1 | Device |
| 2018 | Flushing Problem | 1 | Device |
| 2018 | Fluid/Blood Leak | 14 | Device |
| 2018 | Fitting Problem | 1 | Device |
| 2018 | Filling Problem | 5 | Device |
| 2018 | Failure to Infuse | 66 | Device |
| 2018 | Disconnection | 5 | Device |
| 2018 | Difficult to Remove | 5 | Device |
| 2018 | Difficult to Insert | 3 | Device |
| 2018 | Device Operates Differently Than Expected | 4 | Device |
| 2018 | Device Markings/Labelling Problem | 2 | Device |
| 2018 | Device Fell | 3 | Device |
| 2018 | Device Dislodged or Dislocated | 1 | Device |
| 2018 | Device Damaged Prior to Use | 3 | Device |
| 2018 | Device Contamination with Chemical or Other Material | 3 | Device |
| 2018 | Detachment of Device or Device Component | 8 | Device |
| 2018 | Detachment Of Device Component | 2 | Device |
| 2018 | Deformation Due to Compressive Stress | 3 | Device |
| 2018 | Deflation Problem | 31 | Device |
| 2018 | Defective Device | 2 | Device |
| 2018 | Defective Component | 1 | Device |
| 2018 | Contamination /Decontamination Problem | 1 | Device |
| 2018 | Component Missing | 3 | Device |
| 2018 | Component Falling | 1 | Device |
| 2018 | Complete Blockage | 1 | Device |
| 2018 | Collapse | 1 | Device |
| 2018 | Burst Container or Vessel | 3 | Device |
| 2018 | Break | 42 | Device |
| 2018 | Blocked Connection | 2 | Device |
| 2018 | Bent | 2 | Device |
| 2018 | Appropriate Term/Code Not Available | 3 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2017 | Restricted Flow rate | 1 | Device |
| 2017 | Partial Blockage | 2 | Device |
| 2017 | Packaging Problem | 1 | Device |
| 2017 | Output Problem | 2 | Device |
| 2017 | Occlusion Within Device | 1 | Device |
| 2017 | No Flow | 15 | Device |
| 2017 | No Device Output | 1 | Device |
| 2017 | Mushroomed | 1 | Device |
| 2017 | Melted | 1 | Device |
| 2017 | Material Twisted/Bent | 1 | Device |
| 2017 | Material Fragmentation | 2 | Device |
| 2017 | Manufacturing, Packaging or Shipping Problem | 1 | Device |
| 2017 | Leak/Splash | 4 | Device |
| 2017 | Insufficient Flow or Under Infusion | 1 | Device |
| 2017 | Infusion or Flow Problem | 1 | Device |
| 2017 | Inflation Problem | 21 | Device |
| 2017 | Inaccurate Flow Rate | 1 | Device |
| 2017 | Improper Flow or Infusion | 2 | Device |
| 2017 | Hole In Material | 2 | Device |
| 2017 | Fluid/Blood Leak | 5 | Device |
| 2017 | Filling Problem | 1 | Device |
| 2017 | Failure to Infuse | 2 | Device |
| 2017 | Device Operates Differently Than Expected | 12 | Device |
| 2017 | Device Damaged Prior to Use | 3 | Device |
| 2017 | Device Contamination with Chemical or Other Material | 4 | Device |
| 2017 | Dent in Material | 3 | Device |
| 2017 | Deflation Problem | 3 | Device |
| 2017 | Crack | 2 | Device |
| 2017 | Component Missing | 1 | Device |
| 2017 | Component Falling | 2 | Device |
| 2017 | Burst Container or Vessel | 1 | Device |
| 2017 | Break | 6 | Device |
| 2017 | Bent | 1 | Device |
| 2017 | Aspiration Issue | 1 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2016 | Torn Material | 1 | Device |
| 2016 | Product Quality Problem | 1 | Device |
| 2016 | Out-Of-Box Failure | 1 | Device |
| 2016 | Occlusion Within Device | 1 | Device |
| 2016 | No Flow | 3 | Device |
| 2016 | Material Protrusion/Extrusion | 1 | Device |
| 2016 | Inflation Problem | 4 | Device |
| 2016 | Fluid/Blood Leak | 1 | Device |
| 2016 | Fitting Problem | 1 | Device |
| 2016 | Failure to Infuse | 2 | Device |
| 2016 | Disconnection | 1 | Device |
| 2016 | Difficult to Insert | 1 | Device |
| 2016 | Device Packaging Compromised | 1 | Device |
| 2016 | Device Operates Differently Than Expected | 4 | Device |
| 2016 | Dent in Material | 1 | Device |
| 2016 | Deflation Problem | 1 | Device |
| 2016 | Crack | 1 | Device |
| 2015 | Physical Resistance | 1 | Device |
| 2015 | No Flow | 1 | Device |
| 2015 | Material Protrusion/Extrusion | 1 | Device |
| 2015 | Inflation Problem | 2 | Device |
| 2015 | Failure to Infuse | 3 | Device |
| 2015 | Device Operates Differently Than Expected | 2 | Device |
| 2015 | Device Damaged Prior to Use | 1 | Device |
| 2015 | Dent in Material | 1 | Device |
| 2014 | Difficult to Remove | 1 | Device |
| 2014 | Deflation Problem | 1 | Device |
| 2014 | Component Falling | 1 | Device |