ECOLAB
Received Jan 21, 2016
Report 1047429-2016-00003 · MDR key 5382953
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 IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY THAT CONTAINS A WARMER DRAPE PART # ORS-300N MANUFACTURED BY (B)(4). AVID MEDICAL RECEIVED A COMPLAINT ON (B)(6) 2015 ORIGINATED BY (B)(6) STATING A HOLE IN THE WARMER DRAPE WAS DISCOVERED DURING A PROCEDURE. THE COMPLAINED DRAPE WAS AVAILABLE FOR EVALUATION. AVID MEDICAL ISSUED FORMAL COMPLAINT #(B)(6) TO THE MANUFACTURER (B)(4) 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. (B)(4). ARRANGEMENTS WERE MADE BY (B)(4) TO RETRIEVE THE COMPLAINED DRAPE FOR EVALUATION. NO PATIENT INJURY WAS REPORTED.