MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-12-21 for BACT/ALERT FN CULTURE BOTTLES 259793 manufactured by Biomerieux, Inc..
[748170]
The bottom of an inoculated bact/alert fn plastic bottle removed from the incubator broke into pieces when it was set out to cool down. The customer, who was splattered with blood which had tested positive with e. Coli, was not harmed and no medical treatment was required. There is a potential for an adverse event were this to recur; the user could be exposed to bacteria samples that can have significant health effects.
Patient Sequence No: 1, Text Type: D, B5
[7901696]
An investigation of this incident has been initiated. The customer has been sent a copy of kc5-gcs info 2005-02 "recommendations for subculturing positive bact/alert culture bottles" with recommendations and instructions for venting bottles with high gas procedures. The package insert cautions that "positive culture bottles should be transiently vented... To release any gas produced during microbial metabolism. " the user does not claim any injury due to the event although she was splashed with blood which had registered positive with e. Coli. No medical treatment was reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2007-00009 |
| MDR Report Key | 969453 |
| Report Source | 07 |
| Date Received | 2007-12-21 |
| Date of Report | 2007-12-21 |
| Date of Event | 2007-11-23 |
| Date Mfgr Received | 2007-11-23 |
| Device Manufacturer Date | 2007-08-24 |
| Date Added to Maude | 2008-04-09 |
| 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 | 3 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACT/ALERT FN CULTURE BOTTLES |
| Generic Name | MICROBIAL GROWTH MONITOR |
| Product Code | JTA |
| Date Received | 2007-12-21 |
| Model Number | 259793 |
| Lot Number | 1018006 |
| Device Expiration Date | 2008-08-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 972742 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 100 RODOLPHE ST DURHAM NC 27712 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-21 |