MalfunctionJSC
TSB GROWTH MEDIA
Received Feb 20, 2013 · Event occurred Feb 19, 2013
Report MW5029224 · MDR key 2993981
Device
Product problems
- Microbial Contamination of Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS DISCOVERED THAT A SOY BROTH GROWTH MEDIA USED TO ASSESS STERILITY OF IV PREPARATIONS WAS ALREADY CONTAMINATED WITH BACTERIA BEFORE ANY IV PRODUCT WAS INTRODUCED INTO THE GROWTH MEDIA. THIS IS A PROBLEM THAT PREVENTS THE PHARMACY FROM BEING ABLE TO ACCURATELY DETERMINE IF IV PREPARATIONS ARE STERILE OR CONTAMINATED. THE PRODUCT IS TSB GROWTH MEDIA 100ML - LOT#1129001; EXP: OCT 13, MANUFACTURED BY (B)(4). DATES OF USE: (B)(6) 2013.