BLOOD SPECIMEN COLLECTION DEVICE
This device is manufactured by BECTON DICKINSON AND COMPANY (BD), FRESENIUS MEDICAL CARE NORTH AMERICA.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Short Fill | 1 | Device |
| 2024 | Overfill | 17 | Device |
| 2024 | Leak/Splash | 1 | Device |
| 2024 | Component Missing | 1 | Device |
| 2023 | Short Fill | 6 | Device |
| 2023 | Overfill | 12 | Device |
| 2023 | Device Markings/Labelling Problem | 1 | Device |
| 2023 | Coagulation in Device or Device Ingredient | 1 | Device |
| 2022 | Short Fill | 2 | Device |
| 2022 | Separation Problem | 1 | Device |
| 2022 | Overfill | 1 | Device |
| 2022 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2019 | Volume Accuracy Problem | 17 | Device |
| 2019 | Short Fill | 26 | Device |
| 2019 | Overfill | 90 | Device |
| 2019 | Material Deformation | 1 | Device |
| 2019 | Leak/Splash | 18 | Device |
| 2019 | Incorrect, Inadequate or Imprecise Result or Readings | 13 | Device |
| 2019 | Fluid/Blood Leak | 1 | Device |
| 2019 | Difficult to Insert | 1 | Device |
| 2019 | Device Markings/Labelling Problem | 2 | Device |
| 2019 | Detachment of Device or Device Component | 2 | Device |
| 2019 | Component Missing | 2 | Device |
| 2019 | Coagulation in Device or Device Ingredient | 1 | Device |
| 2019 | Break | 3 | Device |
| 2018 | Volume Accuracy Problem | 27 | Device |
| 2018 | Short Fill | 52 | Device |
| 2018 | Overfill | 171 | Device |
| 2018 | Material Separation | 1 | Device |
| 2018 | Leak/Splash | 7 | Device |
| 2018 | Incorrect, Inadequate or Imprecise Result or Readings | 19 | Device |
| 2018 | Incorrect Or Inadequate Test Results | 10 | Device |
| 2018 | Device Markings/Labelling Problem | 3 | Device |
| 2018 | Device Contamination with Chemical or Other Material | 5 | Device |
| 2018 | Coagulation in Device or Device Ingredient | 5 | Device |
| 2018 | Break | 3 | Device |
| 2017 | Volume Accuracy Problem | 6 | Device |
| 2017 | Short Fill | 18 | Device |
| 2017 | Overfill | 16 | Device |
| 2017 | Leak/Splash | 3 | Device |
| 2017 | Incorrect Or Inadequate Test Results | 12 | Device |
| 2017 | Device Markings/Labelling Problem | 3 | Device |
| 2017 | Device Contamination with Chemical or Other Material | 2 | Device |
| 2017 | Coagulation in Device or Device Ingredient | 5 | Device |
| 2016 | Volume Accuracy Problem | 5 | Device |
| 2016 | Short Fill | 11 | Device |
| 2016 | Overfill | 39 | Device |
| 2016 | Material Deformation | 1 | Device |
| 2016 | Leak/Splash | 5 | Device |
| 2016 | Incorrect Or Inadequate Test Results | 10 | Device |
| 2016 | Device Markings/Labelling Problem | 8 | Device |
| 2016 | Device Contamination with Chemical or Other Material | 3 | Device |
| 2016 | Coagulation in Device or Device Ingredient | 3 | Device |
| 2016 | Break | 1 | Device |
| 2015 | Short Fill | 1 | Device |
| 2015 | Overfill | 3 | Device |
| 2014 | Nonstandard Device | 1 | Device |