MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-08-14 for BACT/ALERT MB CULTURE BOTTLE 251011 manufactured by Biomerieux, Inc..
[892480]
A bact/alert mb blood culture bottle (glass) was found broken in the incubator. The culture was negative for microbacterium, but was positive for enterococcus.
Patient Sequence No: 1, Text Type: D, B5
[8107118]
No adverse event was reported as a result of this broken bottle. The racks were cleaned with alcohol and a 10% solution of bleach. There is a potential for an adverse event were this to recur since the spilled sample could aerosolize, significantly increasing the likelihood or organism transmission.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2008-00005 |
| MDR Report Key | 1120823 |
| Report Source | 05 |
| Date Received | 2008-08-14 |
| Date of Report | 2008-08-15 |
| Date of Event | 2008-07-17 |
| Date Mfgr Received | 2008-07-17 |
| Device Manufacturer Date | 2008-03-01 |
| Date Added to Maude | 2009-05-12 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELIZABETH FRITZ |
| Manufacturer Street | 100 RODOLPHE ST |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACT/ALERT MB CULTURE BOTTLE |
| Generic Name | MICROBIAL GROWTH MONITOR |
| Product Code | JTA |
| Date Received | 2008-08-14 |
| Catalog Number | 251011 |
| Lot Number | 1019790 |
| Device Expiration Date | 2009-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 100 RODOLPHE ST DURHAM NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-08-14 |