MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-12-20 for BACT/ALERT MP CULTURE BOTTLES 259797 manufactured by Biomerieux, Inc..
[791042]
Inoculated bact/alert mp plastic bottles removed from the incubator had "cracks" around the neck of the bottle where it had been cleaned with the disinfectant precise qtb (caltech). On one bottle which had tested negative, the integrity of the bottle had been compromised, and it leaked a small amount that caused the bottle to stick to the instrument cell. The customer followed their lab procedure for clean-up of the spill. The lab has discontinued the use of precise-qtb. There was no pt or results impact due to this issue, nor was there any death or injury related to this complaint.
Patient Sequence No: 1, Text Type: D, B5
[8038443]
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/alert antibiotic supplement (and/or the mb/bact/alert 3d mycobacteria detection systems for the recovery and detection of mycobacteria from sterile body specimens other than blood) and from digested-decontaminated clinical specimens. There is a potential for an adverse event were this to recur and the integrity of a positive bottle were to be compromised. In the event of breakage, the user could be exposed to aerosolized mycobacteria samples that can have significant health effects. The customer has discontinued use of the precise-qtb product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2007-00008 |
| MDR Report Key | 980268 |
| Report Source | 06 |
| Date Received | 2007-12-20 |
| Date of Report | 2007-12-14 |
| Date of Event | 2007-11-20 |
| Date Mfgr Received | 2007-11-20 |
| Device Manufacturer Date | 2007-03-01 |
| Date Added to Maude | 2008-06-19 |
| 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 | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELIZABETH FRITZE |
| 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 | 2007-12-20 |
| Model Number | 259797 |
| Lot Number | 1016249 |
| Device Expiration Date | 2008-03-31 |
| 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 | 981956 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 100 RODOLPHE ST DURHAM NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-20 |