MalfunctionJSC
BACTEC MYCO/F-SPUTA CULTURE VIAL
Received Jul 2, 1997 · Event occurred Jun 9, 1997
Report 1119779-1997-00009 · MDR key 102661
Device
Generic name
Culture Media
Manufacturer
Becton Dickinson Microbiology SystemsModel number
NACatalog number
4402187
Lot number
0157A
Patient
UNKNOWN
Narrative
Description of Event or Problem
CUSTOMER REPORTED LEAKING OF ONE VIAL AFTER INOCULATION OF SPECIMEN. CUSTOMER REPORTED THAT SPECIMEN WAS POSITIVE FOR MYCOBACTERIA. NO DEATH OR SERIOUS INJURY HAS OCCURRED AS A RESULT OF THIS EVENT.
Remedial action
- Inspection
- Replace