inforMED
MalfunctionLIO

BBL CULTURE SWAB PLUS

Received Jul 5, 2002

Report MW1025540 · MDR key 404542

Device

Generic name

Collection And Transport System

Manufacturer

Copan

Model number

*

Catalog number

220116 (BD)

Lot number

1340

Product problems

  • Microbial Contamination of Device

Patient

NA

Narrative

Description of Event or Problem

GRAM-STAINED SMEARS TAKEN OF PT'S WOUNDS RESULTED IN REPORTS OF GRAM NEGATIVE BACTERIA BEING PRESENT ON SEVERAL SPECIMENS. SUSPICIONS WERE RAISED WHEN MULTIPLE SAMPLES SHOWED THE SAME PATTERN BUT NO GROWTH OF BACTERIA WAS SEEN. SMEARS WERE THEN PERFORMED ON PREVIOULSY UNOPENED TRANSPORT MEDIA THAT ALSO RESULTED GRAM NEGATIVE RODS. THE MFR AND DISTRIBUTOR WERE INFORMED OF THIS SITUATION AND WERE ABLE TO REPLICATE THE GROWTH OF GRAM NEGATIVE BACTERIA FROM CULTURES OF STERILE SWABS.