MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-12 for 120 ML BD VACUTAINER? PLASTIC URINE COLLECTION CUP 364975 manufactured by Becton, Dickinson & Co..
[77519963]
Date of event: unknown. The date received by manufacturer has been used for this field. 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
[77519964]
It was reported that three needle stick injuries occurred with a 120 ml bd vacutainer? Plastic urine collection cups because patients stuck there fingers into the transfer device. It appeared that one patient was cut badly because blood was found "everywhere" in the bathroom. No medical interventions were provided and the patients did not notify the lab techs that they had injured themselves. Specific dates and additional information for the three incidents were not able to be obtained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2017-00016 |
| MDR Report Key | 6634979 |
| Date Received | 2017-06-12 |
| Date of Report | 2017-06-06 |
| Date of Event | 2017-05-19 |
| Date Mfgr Received | 2017-05-19 |
| Date Added to Maude | 2017-06-12 |
| 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 | 0 |
| 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 | 120 ML BD VACUTAINER? PLASTIC URINE COLLECTION CUP |
| Generic Name | URINE COLLECTION CUP |
| Product Code | JXA |
| Date Received | 2017-06-12 |
| Catalog Number | 364975 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| 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. Other | 2017-06-12 |