MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-03-27 for BACT/ALERT SA * manufactured by Biomerieux, Inc.
[612693]
A bottle of aerobic bact/alert sa culture solution had no vacuum and inside of vial had a visible grey matter running down side of vial. The vial was not used on a pt. I have notified the mfr by email and we reviewed all our stock here for like lot#.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1042371 |
| MDR Report Key | 833360 |
| Date Received | 2007-03-27 |
| Date of Report | 2007-03-27 |
| Date of Event | 2007-03-20 |
| Date Added to Maude | 2007-04-03 |
| 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 |
| 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 | BACT/ALERT SA |
| Generic Name | * |
| Product Code | JTA |
| Date Received | 2007-03-27 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 1015088 |
| ID Number | REG MS 10158120448 |
| Device Expiration Date | 2007-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 820668 |
| Manufacturer | BIOMERIEUX, INC |
| Manufacturer Address | 100 RANDOLPHE ST DURHAM NC 27712 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-03-27 |