MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-04-30 for BACT MP CULTURE BOTTLES 251010 NA manufactured by Biomerieux, Inc..
[19962914]
A glass bact/alert mp culture bottle was found broken in a bact/alert incubator. The broken bottle sample had flagged positive for mycobacterium and when unloaded, it was noticed that all of the contents had evaporated resulting in potential aerosolization of the organism. There were no adverse patient or healthcare worker events indicated as a result of this incident.
Patient Sequence No: 1, Text Type: D, B5
[20041998]
The bact/alert mp process system consists of the bact/alert mp process bottle with a removable closure used in conjunction with the mb/bact antiobiotic supplement (and/or the mb/bact reconstitution fluid). The bact/alert mp process system is designed for use with the mb/bact or the bact/alert 3d mycobacteria detection systems for recovery and detection of mycobacteria from sterile body specimens other than blood, and from digested-decontaminated clinical specimens. However, there is the potential for adverse events were this to reoccur due to the fact that some mycobacteria samples can have significant health effects and if the sample aerosolized, as it may have in this case, the likelihood of organism transmission is significantly increased.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2007-00002 |
| MDR Report Key | 960979 |
| Report Source | 07 |
| Date Received | 2007-04-30 |
| Date of Report | 2007-04-30 |
| Date of Event | 2007-02-26 |
| Date Added to Maude | 2007-12-11 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | BRIAN BRUNDIDGE, STAFF SPECIALI |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer Phone | 9196202968 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACT MP CULTURE BOTTLES |
| Generic Name | MICROBIAL GROWTH MONITOR |
| Product Code | JTA |
| Date Received | 2007-04-30 |
| Model Number | 251010 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 931042 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 100 RODOLPHE ST DURHAM NC 27712 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-04-30 |