MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-13 for BD VACUTAINER? PLASTIC URINE COLLECTION CUP 364941 manufactured by Becton, Dickinson And Company (bd).
[95073500]
Medical device expiration date: unknown. Device manufacture date: unknown. Results: no sample was received from the customer at the time of this report, however photographs were attached illustrating the reported defects. A review of the device history record could not be performed as a lot number was not provided for this incident. Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer? S indicated failure mode.
Patient Sequence No: 1, Text Type: N, H10
[95073501]
It was reported that bd vacutainer? Plastic urine collection cups were scratched, have traces and don't close correctly. No injury or medical intervention reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617032-2017-00658 |
| MDR Report Key | 7113118 |
| Date Received | 2017-12-13 |
| Date of Report | 2017-12-12 |
| Date of Event | 2017-03-09 |
| Date Mfgr Received | 2017-03-09 |
| Date Added to Maude | 2017-12-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652845 |
| Manufacturer G1 | BECTON, DICKINSON AND COMPANY (BD) |
| Manufacturer Street | BELLIVER WAY BELLIVER INDUSTRIAL ESTATE |
| Manufacturer City | PLYMOUTH |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD VACUTAINER? PLASTIC URINE COLLECTION CUP |
| Generic Name | URINE COLLECTION CUP |
| Product Code | JTW |
| Date Received | 2017-12-13 |
| Catalog Number | 364941 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON AND COMPANY (BD) |
| Manufacturer Address | BELLIVER WAY BELLIVER INDUSTRIAL ESTATE PLYMOUTH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-13 |