ECOLAB/MICROTEK MEDICAL
Received Mar 5, 2018 · Event occurred Feb 1, 2018
Report 1047429-2018-00001 · MDR key 7313167
Product problems
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
AVID MEDICAL ISSUED FORMAL COMPLAINT #(B)(4) TO THE MANUFACTURER ECOLAB/MICROTEK MEDICAL CONCERNING THE WARMER DRAPE LEAKING DURING THE PROCEDURE FOR ITEM NO. ORS-320N, MANUFACTURER LOT# D170801. THE AFFECTED DEVICE WAS NOT AVAILABLE FOR EVALUATION PER END-USER.
Description of Event or Problem
AVID MEDICAL IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY THAT INCLUDES THE FOLLOWING COMPONENT: DRAPE SLUSH WARMER DISC 44X66, VENDOR PART # ORS-320N MANUFACTURED BY ECOLAB/MICROTEK MEDICAL. AVID MEDICAL RECEIVED A COMPLAINT ON (B)(6) 2018 ORIGINATED BY (B)(6), MATERIAL, (B)(6) STATING THAT "IT WAS NOTICED THAT THE WARMING DRAPE HAD LEAKED INTO THE BASIN DURING PROCEDURE." THE AFFECTED DRAPE WAS NOT AVAILABLE FOR EVALUATION. AVID MEDICAL ISSUED FORMAL COMPLAINT #(B)(4) TO THE MANUFACTURER ECOLAB/MICROTEK MEDICAL CONCERNING THE WARMER DRAPE LEAKING DURING THE PROCEDURE FOR ITEM NO. ORS-320N, MANUFACTURER LOT# D170801. NO PATIENT INJURY WAS REPORTED.