MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-10 for BD VACUTAINER? PLASTIC URINE COLLECTION CUP 364941 manufactured by Becton, Dickinson And Company (bd).
[105315070]
There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 7326651, medical device expiration date: 2019-11-30, device manufacture date: 2017-11-22, medical device lot #: 8036911, medical device expiration date: 2020-01-31, device manufacture date: 2018-02-05. (b)(6). A sample is not available for evaluation. However, a no sample investigation and device history record review will be completed. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[105315131]
It was reported that a bd vacutainer? Plastic urine collection cup leaked during use. There was no report of exposure, injury or medical interventions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617032-2018-00074 |
| MDR Report Key | 7413313 |
| Date Received | 2018-04-10 |
| Date of Report | 2018-04-20 |
| Date of Event | 2018-03-13 |
| Date Mfgr Received | 2018-03-22 |
| Date Added to Maude | 2018-04-10 |
| 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 KIT |
| Product Code | JTW |
| Date Received | 2018-04-10 |
| Catalog Number | 364941 |
| Lot Number | SEE H.10 |
| Device Availability | N |
| 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 | 2018-04-10 |