MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-06-25 for BACT/ALERT MP CULTURE BOTTLES 259797 manufactured by Biomerieux, Inc..
[882585]
A plastic bact/alert mp culture bottle was found broken in the bact/alert incubator. Afb stain indicated that its contents were negative. There were no adverse events noted as a result of this incident. The lab was closed and a formaldehyde gas sterilization was performed.
Patient Sequence No: 1, Text Type: D, B5
[8020326]
The user had disinfected the plastic bact/alert mp culture bottle with biocleanse (teknom), a disinfectant, which according to teknon's application chart, is not recommended for the use on polycarbonate bottles. Biomerieux, inc. Has investigated the interaction of some disinfectants on its polycarbonate bottles and has issued a notice alerting users to read the disinfectant's label to determine compatibility with polycarbonate bottles. Biomerieux has also modified its package insert with a caution about polycarbonates and choice of disinfectants by the user.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2008-00002 |
| MDR Report Key | 1065518 |
| Report Source | 06 |
| Date Received | 2008-06-25 |
| Date of Report | 2008-06-20 |
| Date of Event | 2008-05-27 |
| Date Mfgr Received | 2008-05-28 |
| Device Manufacturer Date | 2007-11-01 |
| Date Added to Maude | 2008-09-08 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELISABETH FRITZ |
| Manufacturer Street | 100 RODOLPHE ST |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer Phone | 9196202682 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACT/ALERT MP CULTURE BOTTLES |
| Generic Name | MICROBIAL GROWTH MONITOR |
| Product Code | JTA |
| Date Received | 2008-06-25 |
| Catalog Number | 259797 |
| Lot Number | 1018685 |
| Device Expiration Date | 2008-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1150017 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 100 RODOLPHE ST DURHAM NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-06-25 |