MalfunctionKEM
CITRASOLV
Received Aug 8, 2016 · Event occurred Jul 15, 2016
Report MW5064007 · MDR key 5868015
Device
Product problems
- Contamination
- Device Operates Differently Than Expected
- Device Contamination with Chemical or Other Material
Patient
Not reported
- Tissue Damage
- Tissue Damage
Narrative
Description of Event or Problem
CITRASOLV (DECON LABORATORIES) REAGENT WAS CONTAMINATED WITH GRAY-GREEN TO BROWN MUCOID LIKE SUBSTANCE WHICH INTERFERED WITH THE CLEARING OF TISSUE PROCESSED AT THE (B)(4). THIS RESULTED IN TISSUE DAMAGE THAT REQUIRES RE-PROCESSING (WHICH IS IN PROCESS) AT THE MINIMUM. DATES OF USE: (B)(6) 2016. DIAGNOSIS OR REASON FOR USE: USED TO CLEAR TISSUE BEFORE PARAFFINIZATION OF TISSUE. TISSUE IS THEN CUT AND PLACED ON SLIDES FOR DIAGNOSIS.