MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2009-05-22 for BACT/ALERT SN CULTURE BOTTLE 259790 manufactured by Biomerieux, Inc..
[15697570]
There was small hole in the side of a plastic bactalert sn 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
[15890835]
An investigation of this incident has been initiated. There were no adverse patient 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 samples can have significant health effects. A domino laser etches the lot id and date code on the label. This laser usually has an exposure time of less than 200 milliseconds. However it is possible for the labeler to stop, positioning a bottle in front of the laser. When this occurs, the laser fires a "standby pulse" into the same location for the duration of the pause. This pulse is capable of burning through the bottle if stationary for more than a few seconds. By turning the standby pulse off, the probabiliity of the laser burning a hole in the bottle should be zero. Biomerieux is also investigating a mechanical shield that would drop into place when the labeler turret is not spinning thus preventing an integrity-compromising hole.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2009-00002 |
| MDR Report Key | 1391909 |
| Report Source | 01,05,06,07 |
| Date Received | 2009-05-22 |
| Date of Report | 2009-05-21 |
| Date of Event | 2009-04-23 |
| Date Mfgr Received | 2009-04-23 |
| Device Manufacturer Date | 2008-12-31 |
| Date Added to Maude | 2009-07-07 |
| 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 | MS. ELIZABETH FRITZ |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM, NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer Phone | 9196202682 |
| Manufacturer G1 | BIOMERIEUX, INC. |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM, NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27712 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACT/ALERT SN CULTURE BOTTLE |
| Generic Name | MICROBIAL GROWTH MONITOR |
| Product Code | JTA |
| Date Received | 2009-05-22 |
| Catalog Number | 259790 |
| Lot Number | 1022154 |
| Device Expiration Date | 2009-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 100 RODOLPHE STREET DURHAM, NC 27712 US 27712 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-05-22 |