MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2018-09-21 for BD VACUTAINER? URINE COLLECTION CONTAINER, SCREW CLOSURE 364941 manufactured by Becton, Dickinson And Company (bd).
[121015357]
Date of event: unknown. Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited. Additionally, bd was unable to determine the specific lot number associated with this complaint. Therefore, a review of the device history record could not be conducted. Investigation conclusion: as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd. Root cause description: as there was no sample or photo available for evaluation, a root cause could not be determined. Rationale: complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. The bd business team regularly reviews the collected data for identification of emerging trends.
Patient Sequence No: 1, Text Type: N, H10
[121015358]
It was reported that bd vacutainer? Urine collection container, screw closure caused a needle stick injury. It was reported that this event was potentially a result of insufficient education on the use of the device. No medical intervention was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617032-2018-02816 |
| MDR Report Key | 7897875 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2018-09-21 |
| Date of Report | 2018-09-10 |
| Date of Event | 2018-09-01 |
| Date Mfgr Received | 2018-09-01 |
| Date Added to Maude | 2018-09-21 |
| 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 | 3 |
| Brand Name | BD VACUTAINER? URINE COLLECTION CONTAINER, SCREW CLOSURE |
| Generic Name | SPECIMEN TRANSPORT AND STORAGE CONTAINER |
| Product Code | JTW |
| Date Received | 2018-09-21 |
| Catalog Number | 364941 |
| Lot Number | UNKNOWN |
| 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 | 2018-09-21 |