ECOLAB
Received Apr 28, 2016 · Event occurred Feb 22, 2016
Report 1047429-2016-00012 · MDR key 5616498
Product problems
- Hole In Material
- Torn Material
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
AVID MEDICAL, AN OWENS & MINOR COMPANY, IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY THAT CONTAINS SLUSH DRAPE 66X52, PART # ORS-321N MANUFACTURED BY ECOLAB. ECOLAB RECEIVED A COMPLAINT ON(B)(6) 2016 AND THEN NOTIFIED AVID MEDICAL OF THE COMPLAINT ON 04-14-2016. THIS COMPLAINT WAS ORIGINATED BY (B)(6), ASST. MGR. CARDIO SURGERY, (B)(6) MEDICAL CENTER STATING THAT AFTER THE CASE WAS DONE, A TEAR WAS DISCOVERED IN THE SLUSH DRAPE. THE DRAPE INVOLVED IN THE COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. NO PATIENT INJURY WAS REPORTED. AVID MEDICAL ISSUED FORMAL (B)(4) TO THE MANUFACTURER ECOLAB FOR A HOLE IN THE SLUSH DRAPE-PART NO. ORS-321N. THE SLUSH DRAPE USED IN THE MEDICAL PROCEDURE TRAY CAME FROM LOTS #D153091; D152651.