MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-03-15 for CAREFUSION NDC-57613-007-25 * manufactured by Carefusion.
[2409749]
A surgeon opened a new package of surgical hand scrub and discovered what he thought was a "bug" stuck on the bristles. The product was sequestered and not used. The manufacturer notified and they will send a mailer to return product for analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2495962 |
| MDR Report Key | 2495962 |
| Date Received | 2012-03-15 |
| Date of Report | 2012-03-15 |
| Date of Event | 2012-03-15 |
| Report Date | 2012-03-15 |
| Date Reported to FDA | 2012-03-15 |
| Date Added to Maude | 2012-03-20 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | CAREFUSION |
| Generic Name | SURGICAL HAND SCRUB |
| Product Code | GEC |
| Date Received | 2012-03-15 |
| Model Number | NDC-57613-007-25 |
| Catalog Number | * |
| Lot Number | 0000402093 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 3750 TORREY VIEW COURT SAN DIEGO CA 92130 US 92130 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-15 |