MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-06-28 for BACTISWAB * 12100 manufactured by Remel.
[1615399]
As the nurse was activating the culturette, it broke and plastic particle protruded from the tube causing the nurse to cut her finger.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1753989 |
| MDR Report Key | 1753989 |
| Date Received | 2010-06-28 |
| Date of Report | 2010-06-28 |
| Date of Event | 2010-06-17 |
| Report Date | 2010-06-28 |
| Date Reported to FDA | 2010-06-28 |
| Date Added to Maude | 2010-07-13 |
| 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 | 0 |
| 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 | BACTISWAB |
| Generic Name | WOUND CULTURE SWAB & MEDIUM |
| Product Code | LIO |
| Date Received | 2010-06-28 |
| Model Number | * |
| Catalog Number | 12100 |
| Lot Number | 862518 |
| ID Number | * |
| Operator | NURSE |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | REMEL |
| Manufacturer Address | 12076 SANTA FE DR. LENEXA KS 66215 US 66215 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-28 |