MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2016-12-23 for 120 ML BD VACUTAINER? PLASTIC URINE COLLECTION CUP 364975 manufactured by Becton, Dickinson & Co..
[63231351]
Medical device expiration date: unknown. Device manufacture date: unknown. Results: a sample is not available for evaluation. A review of the device history record could not be performed as a lot number was not provided for this incident. 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. Udi #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[63231352]
It was reported that a healthcare worker (unable to determine if it was a nurse or patient care tech) stuck his/her finger into the well covered by the warning label of a 120 ml bd vacutainer? Plastic urine collection cup and obtained a contaminated needle stick injury. The clinician was evaluated by employee health, received post exposure lab work, and prophylactic medication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2016-00022 |
| MDR Report Key | 6202539 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2016-12-23 |
| Date of Report | 2016-12-19 |
| Date of Event | 2016-06-07 |
| Date Mfgr Received | 2016-12-14 |
| Date Added to Maude | 2016-12-23 |
| 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 | 3 |
| Brand Name | 120 ML BD VACUTAINER? PLASTIC URINE COLLECTION CUP |
| Generic Name | URINE COLLECTION CUP |
| Product Code | JXA |
| Date Received | 2016-12-23 |
| Catalog Number | 364975 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| 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. Required No Informationntervention | 2016-12-23 |