MalfunctionJSC
FAN AEROBIC CULTURE BOTTLES
Received Aug 7, 1997 · Event occurred Aug 5, 1997
Report MW1011852 · MDR key 111574
Device
Generic name
Blood Culture Bottle
Manufacturer
Organon Teknika Corp.Model number
FAN AEROBIC BOTTLECatalog number
55948
Lot number
203899
Product problems
- Microbial Contamination of Device
- Out-Of-Box Failure
Patient
10 MO
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
BLOOD WAS DRAWN FROM THIS PT AND PLACED IN A FAN BLOOD CULTURE BOTTLE. WHEN THE BOTTLE WAS RECEIVED IN THE LAB, THE BOTTOM WAS NOTED TO BE YELLOW INDICATING A POSITIVE BOTTLE. LESS THAN 1 HR. HAD ELAPSED FROM THE TIME OF COLLECTION TO THE TIME OF RECEIPT IN THE LAB. RPTR CONCLUDED THAT THE BOTTLE MUST HAVE BEEN CONTAMINATED PRIOR TO INOCULATION. THIS APPEARS TO BE A DEFECTIVE PRODUCT FROM THE MFR.