MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-09 for BD VACUTAINER? PLASTIC URINE COLLECTION CUP WITH INTEGRATED SAMPLING DEVICE 364975 manufactured by Becton, Dickinson & Co..
[31082938]
Results- a sample is not available for investigation. A review of the device history record cannot be completed as the lot number was not provided for this incident. Conclusion- without a sample, an absolute root cause for this incident cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[31082939]
It was reported that a lab tech received a sample in a bd vacutainer plastic urine collection cup. The device's lid was wrapped with parafilm to prevent leaking and the protective cover on the needle was not in place. As the tech was trying to remove the lid from the cup, the index finger of his left hand went inside the lid receptacle and he stuck himself on the needle. He was evaluated for bloodborne pathogens. The source patient was seeing an infectious disease doctor for (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2015-00001 |
| MDR Report Key | 5210728 |
| Date Received | 2015-11-09 |
| Date of Report | 2015-11-06 |
| Date of Event | 2015-10-15 |
| Date Mfgr Received | 2015-10-16 |
| Date Added to Maude | 2015-11-09 |
| 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 WITH INTEGRATED SAMPLING DEVICE |
| Generic Name | COLLECTION CUP |
| Product Code | OIE |
| Date Received | 2015-11-09 |
| Catalog Number | 364975 |
| Lot Number | UNKNOWN |
| Device Availability | * |
| 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 | 2015-11-09 |