MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-09-07 for AFFIRM VPIII * 446255 manufactured by Becton Dickinson.
[2893728]
While physician was preparing a vaginal specimen container prior to a pelvic exam, she squeezed the plastic vial to release the reagent that is contained in the inner glass vial. When the inner vial broke, a glass shard penetrated the plastic and punctured the md's finger. The physician is ok. Staff are not aware of this happening before. The container and packaging were discarded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2749624 |
| MDR Report Key | 2749624 |
| Date Received | 2012-09-07 |
| Date of Report | 2012-09-07 |
| Date of Event | 2012-09-04 |
| Report Date | 2012-09-07 |
| Date Reported to FDA | 2012-09-07 |
| Date Added to Maude | 2012-09-19 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AFFIRM VPIII |
| Generic Name | SPECIMEN TRANSPORT AND STORAGE CONTAINER |
| Product Code | LIO |
| Date Received | 2012-09-07 |
| Model Number | * |
| Catalog Number | 446255 |
| Lot Number | 2033348 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | ONE BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-07 |