MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-05 for BD VACUTAINER? PLASTIC URINE COLLECTION CUP 364941 manufactured by Becton, Dickinson & Co..
[94510512]
Medical device lot #: 6272821; medical device expiration date: 10/31/2018; device manufacture date: 9/28/2016. Medical device lot #: 6245937; medical device expiration date: 9/30/2018; device manufacture date: 9/1/2016. Medical device lot #: 6245936; medical device expiration date: 9/30/2018; device manufacture date: 9/1/2016. Medical device lot #: 6147549; medical device expiration date: 6/30/2018; device manufacture date: 5/26/2016. Medical device lot #: 6147547; medical device expiration date: 6/30/2018; device manufacture date: 5/26/2016. Medical device lot #: 6061829; medical device expiration date: 3/31/2018 ;device manufacture date: 3/1/2016. Results: a sample was not returned for evaluation. 1 photo was returned by customer. Bd pas was unable to confirm customer incident by the photo. There were no related quality notifications for any of the lots referenced. All process and final inspections comply with specification requirements. 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
[94510513]
It was reported that bd vacutainer? Plastic urine collection cup had containers that could not be fully closed causing leaks. No injury or medical intervention reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2017-00464 |
| MDR Report Key | 7083697 |
| Date Received | 2017-12-05 |
| Date of Report | 2017-11-09 |
| Date of Event | 2017-04-11 |
| Date Mfgr Received | 2017-04-11 |
| Device Manufacturer Date | 2016-09-28 |
| Date Added to Maude | 2017-12-05 |
| 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 & CO. |
| Manufacturer Street | 150 SOUTH 1ST AVENUE |
| Manufacturer City | BROKEN BOW NE 68822 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68822 |
| 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 | 2017-12-05 |
| Catalog Number | 364941 |
| Lot Number | 6272822 |
| Device Expiration Date | 2018-10-31 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON & CO. |
| Manufacturer Address | 150 SOUTH 1ST AVENUE BROKEN BOW NE 68822 US 68822 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-05 |