ECOLAB
Received Nov 25, 2015 · Event occurred Nov 3, 2015
Report 1047429-2015-00007 · MDR key 5250653
Device
Product problems
- Hole In Material
Patient
Not reported
- 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 # OEM-ORS-100N MANUFACTURED BY ECOLAB. AVID MEDICAL RECEIVED A COMPLAINT ON (B)(4) 2015 ORIGINATED BY (B)(6), STATING THAT THEY FOUND PIN HOLES IN THEIR FLUID WARMER DRAPES AND THAT ONE DRAPE WAS USED ON A PATIENT. (B)(6) WAS NOT SURE HOW MANY DRAPES HAD HOLES. AVID MEDICAL AND ECOLAB WERE BOTH NOTIFIED OF THIS COMPLAINT ON (B(4) 2015 BY THE ORIGINATOR (B)(6). AVID MEDICAL ISSUED FORMAL COMPLAINT (B)(4) TO ECOLAB ON (B)(4) 2015 FOR PIN HOLES IN WARMER DRAPE PART #OEM-ORS-100N, LOT # D152251A. NO FURTHER INFORMATION ON THE PATIENT IS AVAILABLE.