MalfunctionKSE
RED BLOOD CELL FREEZING PACK
Received Aug 5, 2010 · Event occurred Jul 26, 2010
Report MW5017024 · MDR key 1793625
Device
Generic name
Red Blood Cell Freezing Pack
Catalog number
4R2422
Lot number
FA09J08046
Product problems
- Leak/Splash
- Split
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
DURING GLYCEROLIZATION PROCESS AT OUR FACILITY, WE DISCOVERED A SLIT NEAR THE SEAM ON FENWAL 2L BAG WITH PRODUCT CODE (B)(4) AND LOT # FA09J08046. DURING THE 2ND PHASE OF WASHING AND CONCENTRATION OF CT PRODUCT, WE DISCOVERED LEAKS NEAR THE SEAM ON FENWAL 2L BAG WITH PRODUCT CODE (B)(4) AND LOT # FA10B19079.