ECOLAB
Received Feb 17, 2016 · Event occurred Jan 21, 2016
Report 1047429-2016-00007 · MDR key 5442174
Device
Product problems
- Hole In 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 A WARMER DRAPE PART # ORS-300N MANUFACTURED BY ECOLAB. AVID MEDICAL RECEIVED A COMPLAINT ON (B)(4) 2016 ORIGINATED BY (B)(6) STATING A HOLE IN THE WARMER DRAPE WAS DISCOVERED AT THE END OF A PROCEDURE. THE COMPLAINED DRAPE WAS NOT AVAILABLE FOR EVALUATION. NO PATIENT INJURY WAS REPORTED. AVID MEDICAL ISSUED FORMAL COMPLAINT (B)(4) TO THE MANUFACTURER ECOLAB FOR A HOLE IN THE WARMER DRAPE - PART # ORS-300N. THE FOLLOWING WARMER DRAPE LOT #'S WERE USED TO BUILD AVID MEDICAL'S CUSTOM PROCEDURE TRAY D151941ARC, D151671ARC, D151671RC, D151661RC, D151731RC, D151821RC3.