inforMED
MalfunctionJSC

BACTEC MYCO/F-SPUTA CULTURE VIAL

Received Jul 2, 1997 · Event occurred Jun 11, 1997

Report 1119779-1997-00011 · MDR key 102667

Device

Generic name

Culture Media

Model number

NA

Catalog number

4402187

Lot number

0157A

Patient

UNKNOWN

Narrative

Description of Event or Problem

CUSTOMER REPORTED LEAKING OF 2 VIALS AFTER INOCULATION OF SPECIMEN. CUSTOMER REPORTED THAT BOTH SPECIMENS WERE NEGATIVE FOR MYCOBACTERIA. NO DEATH OR SERIOUS INJURY HAS OCCURRED AS A RESULT OF THIS EVENT.

Remedial action

  • Replace
  • Inspection