D
Patient 1
A BACT/ALERT MB BLOOD CULTURE BOTTLE (GLASS) WAS FOUND BROKEN IN THE INCUBATOR. THE CULTURE WAS NEGATIVE FOR MICROBACTERIUM, BUT WAS POSITIVE FOR ENTEROCOCCUS.
MAUDE MDR 1120823
- MDR report key
- 1120823
- Report number
- 3002769706-2008-00005
- Event key
- 0
- Event type
- 3
- Date of event
- 2008-07-17
- Date received
- 2008-08-14
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- ELIZABETH FRITZ
- Address
- 100 RODOLPHE ST DURHAM NC 27712 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BACT/ALERT MB CULTURE BOTTLE | MICROBIAL GROWTH MONITOR | BIOMERIEUX, INC. | JTA | 251011 | 1019790 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2008-08-14 | 0 |
Event Narratives#
N
Patient 1
NO ADVERSE EVENT WAS REPORTED AS A RESULT OF THIS BROKEN BOTTLE. THE RACKS WERE CLEANED WITH ALCOHOL AND A 10% SOLUTION OF BLEACH. THERE IS A POTENTIAL FOR AN ADVERSE EVENT WERE THIS TO RECUR SINCE THE SPILLED SAMPLE COULD AEROSOLIZE, SIGNIFICANTLY INCREASING THE LIKELIHOOD OR ORGANISM TRANSMISSION.