ECOLAB
Received Jan 21, 2016
Report 1047429-2016-00006 · MDR key 5383019
Device
Product problems
- 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 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) REPORTING A TEAR IN A WARMER DRAPE. THE COMPLAINED DRAPE WAS AVAILABLE FOR EVALUATION. AVID MEDICAL ISSUED FORMAL COMPLAINT #(B)(4) TO THE MANUFACTURER (B)(4) STATING A WARMER DRAPE TORE - PART # ORS-300N. THE FOLLOWING WARMER DRAPE LOT #'S WERE USED TO BUILD AVID MEDICAL'S CUSTOM PROCEDURE TRAY D151391RC, D151401RC, DA152591, D152651, D152661. ARRANGEMENTS WERE MADE BY (B)(4) TO RETRIEVE THE COMPLAINED DRAPE FOR EVALUATION. NO PATIENT INJURY WAS REPORTED.