MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-04-14 for BD manufactured by .
[21718408]
Lab student was using a urine container in the lab when she accidentally stuck herself with contaminated needle embedded in cap of device. This is the second such event we have had at our facility. [prior event occurred within last yr with new employee]. The device is a bd vacutainer for urine with a blue cap. It has a yellow sticker on the top which states "pt: do not remove label/nurse: replace label after sampling. " it is not clearly labeled that it contains a needle under the label. This student stuck her finger in the hole- unaware that it was a needle and sustained a puncture wound. This necessitated follow up for possible exposure to blood born pathogens.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5006285 |
| MDR Report Key | 1029683 |
| Date Received | 2008-04-14 |
| Date of Report | 2008-04-14 |
| Date of Event | 2008-03-11 |
| Date Added to Maude | 2008-04-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD |
| Generic Name | URINE VACUTAINER |
| Product Code | LIO |
| Date Received | 2008-04-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 998459 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-04-14 |