ECOLAB
Received Dec 17, 2015 · Event occurred Nov 20, 2015
Report 1047429-2015-00010 · MDR key 5307669
Product problems
- Leak/Splash
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
AVID MEDICAL IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY THAT CONTAINS A WARMER DRAPE PART # ORS-100N MANUFACTURED BY ECOLAB. AVID MEDICAL RECEIVED A COMPLAINT ON (B)(6) 2015 ORIGINATED BY (B)(6), OR MANAGER OF (B)(6) STATING THE WARMING DRAPE LEAKED INTO THE WARMING PAN AND WAS DISCOVERED AT THE END OF THE CASE. THE WARMER DRAPE THAT WAS THE SUBJECT OF THE COMPLAINT WAS DISPOSED OF BY THE MEDICAL CENTER AFTER THE CASE. AVID MEDICAL ISSUED FORMAL COMPLAINT #(B)(4) TO THE MANUFACTURER ECOLAB FOR THE WARMER DRAPE LEAK INTO THE WARMER PAN - PART # ORS-100N. THE FOLLOWING WARMER DRAPE LOT #'S WERE USED TO BUILD AVID MEDICAL'S CUSTOM PROCEDURE TRAY; (B)(4). NO PATIENT INJURY WAS REPORTED.