MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-28 for BD VACUTAINER? PLASTIC URINE COLLECTOR CUP 364941 manufactured by Becton, Dickinson And Company (bd).
[134362951]
Date of event: unknown. The date received by manufacturer has been used for this field. (b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[134362955]
It was reported that bd vacutainer? Plastic urine collector cups were not correctly closed, resulted in sterility breach. The other cups were little bit screwed, but they were opened at the moment of taking them by cover before use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617032-2019-00131 |
| MDR Report Key | 8283795 |
| Date Received | 2019-01-28 |
| Date of Report | 2019-03-20 |
| Date of Event | 2019-01-21 |
| Date Mfgr Received | 2019-01-21 |
| Device Manufacturer Date | 2018-07-03 |
| Date Added to Maude | 2019-01-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 COLLECTOR CUP |
| Generic Name | SPECIMEN TRANSPORT AND STORAGE CONTAINER |
| Product Code | JTW |
| Date Received | 2019-01-28 |
| Catalog Number | 364941 |
| Lot Number | 8184743 |
| Device Expiration Date | 2018-07-03 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-01-28 |