MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-07-26 for BTA CLASSIC 240 INSTRUMENT 259791 manufactured by Biomerieux Inc..
[19489692]
The bact fa bottle is a microbial growth monitor for aerobic and facultative anaerobic microorganisms. This complaint was for contamination present in 4 fa aerobic bottles. Contamination was determined to be paenibacillus sp. These bottles were collected from 3 separate locations within the customer facility. No injuries or unnecessary medical treatments resulted from this incident. In addition, any necessary pt medical treatments were not delayed as a result of these results. The customer was, however, required to perform additional testing on the samples.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2005-00028 |
| MDR Report Key | 719962 |
| Report Source | 07 |
| Date Received | 2005-07-26 |
| Date of Report | 2005-07-25 |
| Date of Event | 2005-07-05 |
| Date Mfgr Received | 2005-07-05 |
| Date Added to Maude | 2006-05-31 |
| 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, SPECIALIST |
| Manufacturer Street | 100 RODOLPHE ST. |
| 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 | NO |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BTA CLASSIC 240 INSTRUMENT |
| Generic Name | MICROBIAL GROWTH MONITOR |
| Product Code | JTA |
| Date Received | 2005-07-26 |
| Model Number | NA |
| Catalog Number | 259791 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 709031 |
| Manufacturer | BIOMERIEUX INC. |
| Manufacturer Address | 100 RODOLPHE ST DURHAM NC 27712 US |
| Baseline Brand Name | BACT/ALERT FA PLASTIC BOTTLE |
| Baseline Generic Name | MICROBIAL GROWTH MONITOR |
| Baseline Model No | NA |
| Baseline Catalog No | 259791 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-07-26 |