MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-01-12 for BD AFFIRM VP III manufactured by Becton, Dickinson And Co..
[2567931]
Bd affirm collection device has a glass ampule inside which must be squeezed to break. The nurse broke the ampule and the glass stabbed through the side of the plastic collection device and puncture her finger. The skin was broken but did not need medical attention other than a band aid.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5023814 |
| MDR Report Key | 2419231 |
| Date Received | 2012-01-12 |
| Date of Report | 2012-01-04 |
| Date of Event | 2012-01-02 |
| Date Added to Maude | 2012-01-19 |
| 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 | 0 |
| 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 AFFIRM VP III |
| Generic Name | AFFIRM |
| Product Code | MLA |
| Date Received | 2012-01-12 |
| Lot Number | 1186060 |
| Device Expiration Date | 2013-01-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON AND CO. |
| Manufacturer Address | SPARKS MD 21152 US 21152 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-01-12 |