MalfunctionJSC
THOGLYCOLLATE CULTURE MEDIA
Received Nov 1, 1994 · Event occurred Oct 18, 1994
Report MW1003854 · MDR key 17315
Device
Generic name
Culture Media
Manufacturer
Pml MicrobiologicalsCatalog number
T3640
Lot number
081601T, 081602T, 081701T
Product problems
- Contamination
Patient
*
Narrative
Description of Event or Problem
ON 10/18/94 MICRO PERSONNEL NOTED THAT SOME UNINOCULATED THIOGLYCOLLATE BROTHS (THIOS) WERE GROWING MOLDS. SEVERAL PTS' CULTURES GREW OUT MOLDS ALSO. INVESTIGATION OF THIOS SHOWS MOLD GROWING ON LABELS AND SHIPPING CARTONS. INVESTIGATION OF POSITIVE CULTURES SHOWS NO MOLD ISOLATED ON REPEAT CULTURES (WHEN POSSIBLE) OR THAT THE PTS' CLINICAL PRESENTATION DOES NOT IMPLICATE A FUNGAL INFECTION. ALL THIOS OF IMPLICATED LOTS WERE DISCARDED 10/25/94.