MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-08 for BD VACUTAINER? URINE COLLECTION CUP 364941 manufactured by Becton, Dickinson And Company (bd).
[107824440]
Date of event: unknown. The date received by manufacturer has been used for this field. Bd received samples from the customer facility for investigation. The samples were evaluated and the customer's indicated failure mode with the incident lot was observed. A review of the manufacturing records was completed for the incident lot and no issues were identified. Bd has initiated a capa to document further investigation and root cause(s) of this product issue.
Patient Sequence No: 1, Text Type: N, H10
[107824441]
While using the bd vacutainer? Urine collection cups, it was reported that "half of urine cups are without needles".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617032-2018-01245 |
| MDR Report Key | 7495760 |
| Date Received | 2018-05-08 |
| Date of Report | 2018-05-08 |
| Date of Event | 2018-03-02 |
| Date Mfgr Received | 2018-03-02 |
| Device Manufacturer Date | 2018-01-10 |
| Date Added to Maude | 2018-05-08 |
| 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? URINE COLLECTION CUP |
| Generic Name | SPECIMEN TRANSPORT AND STORAGE CONTAINER |
| Product Code | LIO |
| Date Received | 2018-05-08 |
| Returned To Mfg | 2018-03-12 |
| Catalog Number | 364941 |
| Lot Number | 8010514 |
| Device Expiration Date | 2019-12-31 |
| Device Availability | R |
| 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 | 2018-05-08 |