inforMED
MalfunctionJSC

BBL MYCOBACTERIA GROWTH INDICATOR 7ML TUBE

Received May 11, 2001 · Event occurred Apr 12, 2001

Report 1119779-2001-00003 · MDR key 333118

Device

Generic name

Culture Media

Model number

NA

Catalog number

245122 (FORMERLY 4345122)

Lot number

0258228

Product problems

  • Fluid/Blood Leak

Patient

*

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

AN INNOCULATED TUBE LEAKED 1-2 ML OF LIQUID INTO THE INSTRUMENT. FOUR WEEKS AFTER THE INCIDENT THE SPECIMEN IS NEGATIVE FOR MYCOBACTERIA ALONG WITH TWO OTHER SAMPLES FFROM THE SAME PATIENT. ONLY A STREPTOCOCCUS SPP. WAS ISOLATED. NO DEATH OR SERIOUS INJURY HAS OCURRED AS A RESULT OF THIS EVENT.