MalfunctionJSC
BACTEC MYCO/F-SPUTA CULTURE VIAL
Received May 7, 1997 · Event occurred Apr 11, 1997
Report 1119779-1997-00003 · MDR key 89539
Device
Generic name
Culture Media
Manufacturer
Becton Dickinson Microbiology SystemsModel number
NACatalog number
4402187
Lot number
0157A
Product problems
- Leak/Splash
Patient
UNKNOWN
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
CUSTOMER REPORTED LEAKING AROUND BOTTLE CRIMPING AFTER INOCULATION OF SPECIMEN. CUSTOMER REPORTED SEAL APPEARED LOOSE AND NOT TIGHTLY SEATED. BOTTLE DISCARDED. NO DEATH OR SERIOUS INJURY AS A RESULT OF THIS EVENT.
Remedial action
- Replace
- Inspection