MalfunctionLIO
BBL CULTURE SWAB PLUS
Received Jul 5, 2002
Report MW1025540 · MDR key 404542
Device
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.