MalfunctionLHC
ECOLAB
Received Feb 18, 2016 · Event occurred Oct 9, 2015
Report 1047429-2016-00008 · MDR key 5444278
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
(B)(4), IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY THAT CONTAINS A WARMER DRAPE PART # ORS-320N MANUFACTURED BY ECOLAB. (B)(4) RECEIVED A COMPLAINT ON (B)(6) 2016 ORIGINATED BY (B)(6) OF (B)(6) HOSPITAL STATING A SMALL 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. (B)(4) ISSUED FORMAL COMPLAINT (B)(4) TO THE MANUFACTURER ECOLAB FOR A HOLE IN THE WARMER DRAPE - PART # ORS-320N. THE FOLLOWING WARMER DRAPE LOT #'S WERE USED TO BUILD (B)(4) CUSTOM PROCEDURE TRAY (B)(4).