MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-01-10 for BACTISWAB II manufactured by Remel.
[745863]
The item failed when the glass ampule was being broken to moisten the swab mrsa culture. The shards from the ampule pierced the outer barrier of the device and the employee's glove and hand. The failure occurred on two sequential attempts by two employees with the last two devices in the lot. No defects have been found in other lots. The two employees received right thumb lacerations. The employees were f/u with blood work, which returned as neg for mrsa.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5004985 |
| MDR Report Key | 980144 |
| Date Received | 2008-01-10 |
| Date of Report | 2008-01-10 |
| Date of Event | 2007-12-12 |
| Date Added to Maude | 2008-01-23 |
| 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 | BACTISWAB II |
| Generic Name | BACTISWAB |
| Product Code | JSL |
| Date Received | 2008-01-10 |
| Lot Number | 601179 |
| Device Expiration Date | 2010-10-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 949292 |
| Manufacturer | REMEL |
| Manufacturer Address | LENEXA KS 66215 US |
| Brand Name | BACTISWAB II |
| Generic Name | BACTISWAB |
| Product Code | JSL |
| Date Received | 2008-01-10 |
| Lot Number | 601179 |
| Device Expiration Date | 2010-10-25 |
| Operator | HEALTH PROFESSIONAL |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 2 |
| Device Event Key | 949293 |
| Manufacturer | REMEL |
| Manufacturer Address | LENEXA KS 66215 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-01-10 |