MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2008-11-13 for BACT/ALERT MP CULTURE BOTTLE 259797 manufactured by Biomerieux, Inc..
[2690333]
There was a 1mm hole in the side of a plastic bactalert mp bottle. Since the hole was covered by the product label, it was not seen on visual examination, and the bottle was inoculated and incubated. During incubation, blood and medium oozed through the hole saturating the label and dripping into the cell of the incubator.
Patient Sequence No: 1, Text Type: D, B5
[9822635]
An investigation of this incident has been initiated. There were no adverse pt or healthcare worker events associated with this incident. However, there is the potential for adverse events were this to recur since the exposure to some mycobacterial samples can have significant health effects. Conclusions: unusual event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2008-00008 |
| MDR Report Key | 2555665 |
| Report Source | 05,06,07 |
| Date Received | 2008-11-13 |
| Date of Report | 2008-11-13 |
| Date of Event | 2008-10-16 |
| Date Mfgr Received | 2008-10-16 |
| Device Manufacturer Date | 2008-03-01 |
| Date Added to Maude | 2012-05-03 |
| 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 MP CULTURE BOTTLE |
| Generic Name | MICROBIAL GROWTH MONITOR |
| Product Code | JTA |
| Date Received | 2008-11-13 |
| Returned To Mfg | 2008-10-23 |
| Catalog Number | 259797 |
| Lot Number | 102075 |
| Device Expiration Date | 2009-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2008-11-13 |