MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-03-30 for BACT/ALERT FN CULTURE BOTTLE 259790 manufactured by Biomerieux, Inc..
[1266216]
An incubator module rack was contaminated by spilled medium from a positive culture bottle which contained serratia spp. It was reported that the aluminum crimp seal was missing from the culture bottle and the rubber stopper was dislodged. There was no adverse event associated with this incident.
Patient Sequence No: 1, Text Type: D, B5
[8527365]
An investigation of this incident has been initiated. The customer alleges that the aluminum crimp seal was missing prior to use. The complaint states that the user removed the flip cap and inoculated the bottle through the rubber stopper without noticing that the aluminum seal was missing. This is an unlikely scenario since the flip top is attached to the crimp seal which covers the rubber stopper. The picture provided by the user shows the rubber stopper with "dents" or gauges in the rubber stopper. The instructions for use advise to visually inspect the bottles prior to use and not to use if there is evidence of damage, leakage or deterioration.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2009-00001 |
| MDR Report Key | 1418559 |
| Report Source | 06 |
| Date Received | 2009-03-30 |
| Date of Report | 2009-03-16 |
| Date of Event | 2009-03-02 |
| Date Mfgr Received | 2009-03-02 |
| Device Manufacturer Date | 2008-08-01 |
| Date Added to Maude | 2010-05-11 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELIZABETH 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 FN CULTURE BOTTLE |
| Generic Name | MICROBIAL GROWTH MONITOR |
| Product Code | JTA |
| Date Received | 2009-03-30 |
| Catalog Number | 259790 |
| Lot Number | 1021290 |
| 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 | 2009-03-30 |