MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-08-08 for BACT/ALERT? SA CULTURE BOTTLE 259789 manufactured by Biomerieux Inc..
[188988376]
A customer in the united states notified biom? Rieux of recovering bacillus species when testing with bact/alert? Sa bottles (lots 1052576, 1053278 and 1053002), bact/alert sn bottles (lots 1053350, 1052950 and 1053162) and bact/alert fa bottles (lot 1053482). The customer reported that the suspected contamination of bacillus was obtained for multiple patients. The customer stated there was no delay in reporting results. The customer reported the physician suspected the results were contamination. No patient was treated for bacillus. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2019-00032 |
| MDR Report Key | 8876614 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-08-08 |
| Date of Report | 2019-08-08 |
| Date Mfgr Received | 2019-08-07 |
| Device Manufacturer Date | 2019-02-11 |
| Date Added to Maude | 2019-08-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CANDACE MARTIN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX INC. |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27712 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACT/ALERT? SA CULTURE BOTTLE |
| Generic Name | BACT/ALERT? SA CULTURE BOTTLE |
| Product Code | MDB |
| Date Received | 2019-08-08 |
| Catalog Number | 259789 |
| Lot Number | 1053002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX INC. |
| Manufacturer Address | 100 RODOLPHE STREET DURHAM NC 27712 US 27712 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-08 |