MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-07 for BD VACUTAINER? PLASTIC URINE COLLECTION CUP 364941 manufactured by Becton, Dickinson And Company (bd).
[94824121]
Date of event: unknown. Bd had not received any sample or photo from the customer facility for evaluation; therefore, the investigation was limited. Further investigation activities were conducted, and a potential root cause has been identified. Although no issues were identified within the dhr, examination of the processing equipment which tightens the lid to the cup determined that the alignment of the torque station was incorrect. This prevented the caps from being securely attached to the cups in some cases. Conclusion: bd was able to confirm the customer? S indicated failure mode from the examination of the processing equipment.
Patient Sequence No: 1, Text Type: N, H10
[94824122]
It was reported that a bd vacutainer? Plastic urine collection cup had a lid that was not properly screwed on. Customer worried about the cup sterility (as meant to be sterile inside). There was no report of serious injury or medial intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617032-2017-00482 |
| MDR Report Key | 7095684 |
| Date Received | 2017-12-07 |
| Date of Report | 2017-11-16 |
| Date of Event | 2017-06-15 |
| Date Mfgr Received | 2017-06-15 |
| Device Manufacturer Date | 2017-03-24 |
| Date Added to Maude | 2017-12-07 |
| 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 SET |
| Product Code | JTW |
| Date Received | 2017-12-07 |
| Catalog Number | 364941 |
| Lot Number | 7083805 |
| Device Expiration Date | 2019-03-31 |
| 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 | 2017-12-07 |