MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-07-30 for BACT/ALERT SN CULTURE BOTTLE 259790 manufactured by Biomerieux, Inc..
[915418]
While removing a bact/alert sn plastic culture bottle from the bact/alert instrument, the cap of the bottle came off. Contents of the bottle spilled onto the incubator and the technician. No injury or adverse impact from this event was reported.
Patient Sequence No: 1, Text Type: D, B5
[7884847]
An investigation of this incident has been initiated. Customer threw away bottle and no pictures are available. If additional info becomes available, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2008-00003 |
| MDR Report Key | 1084491 |
| Report Source | 06 |
| Date Received | 2008-07-30 |
| Date of Report | 2008-07-28 |
| Date of Event | 2008-07-02 |
| Date Mfgr Received | 2008-07-02 |
| Device Manufacturer Date | 2008-05-01 |
| Date Added to Maude | 2009-02-09 |
| 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 | 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 SN CULTURE BOTTLE |
| Generic Name | MICROBIAL GROWTH MONITOR |
| Product Code | JTA |
| Date Received | 2008-07-30 |
| Catalog Number | 259790 |
| Lot Number | 1020363 |
| Device Expiration Date | 2009-05-31 |
| 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 | 2008-07-30 |