ECOLAB
Received Jun 2, 2016 · Event occurred Apr 20, 2016
Report 1047429-2016-00014 · MDR key 5694494
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 (B)(4), IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY THAT CONTAINS DRAPE, ORS WARMING 44"X66" POLY, PART # ORS-300N MANUFACTURED BY ECOLAB. AVID MEDICAL RECEIVED A COMPLAINT ON (B)(6) 2016 ORIGINATED BY (B)(6), CBMET, (B)(6) MEDICAL CENTER REPORTING THE FINDING OF A SMALL HOLE IN THE DRAPE AFTER THE SURGICAL CASE WAS FINISHED. NO PATIENT INJURY WAS REPORTED. AVID MEDICAL ISSUED FORMAL COMPLAINT #(B)(4) TO THE MANUFACTURER ECOLAB FOR A SMALL HOLE IN WARMING DRAPE PART# ORS-300N. THE COMPLAINED DRAPE WAS SENT TO ECOLAB, FOR EVALUATION. THE FOLLOWING DRAPE LOT NUMBERS WERE USED TO BUILD AVID MEDICAL'S CUSTOM PROCEDURE TRAY: D153061A, D153151, D153151A, DA153151.