MalfunctionJSC
BACTEC MYCO/F-SPUTA CULTURE VIAL
Received Jun 4, 1997 · Event occurred May 28, 1997
Report 1119779-1997-00008 · MDR key 96393
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 CRIMPING OF 6 VIALS AFTER INOCULATION OF SPECIMEN. CUSTOMER REPORTED SEAL APPEARED LOOSE AND NOT TIGHTLY SEALED. NO DEATH OR SERIOUS INJURY HAS OCCURRED AS A RESULT OF THIS EVENT.