ECOLAB
Received Jun 17, 2016 · Event occurred May 19, 2016
Report 1047429-2016-00016 · MDR key 5733373
Device
Product problems
- Fluid/Blood Leak
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 OWENS & MINOR COMPANY, IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY THAT CONTAINS DRAPE,ORS WARMING 44"X44" POLY, PART # ORS-100N MANUFACTURED BY ECOLAB. AVID MEDICAL RECEIVED A COMPLAINT ON 05/26/2016 ORIGINATED BY (B)(6), OPERATING ROOM (OR) OFFICE CLERK, (B)(6) GENERAL HOSPITAL STATING THAT THE SURGEON NOTED A LEAK IN SOME OF THE DRAPES. HE HAS FOUND A SMALL AMOUNT OF FLUID (LESS THAN 50CC) BETWEEN THE DRAPE AND FLUID WARMER IN TWO CASES. THE COMPLAINT IDENTIFIED 2 DRAPES, SO THIS IS MDR # 1 OF 2 ORIGINATING WITH THIS COMPLAINT. THE COMPLAINED DRAPES WERE NOT AVAILABLE FOR EVALUATION. AVID MEDICAL ISSUED FORMAL (B)(4) TO THE MANUFACTURER ECOLAB FOR A LEAK IN WARMING DRAPE NO. ORS-100N. THE DRAPE LOT # ARE AS FOLLOWS: D151621ARHVO,D151751RHVO,D153071,D153081,D153011,D153021,D151341,D153081A,D153091,D152891,D153011A,D151971RHVO,D151611RHVO,D152941,D152761A. NO PATIENT INJURY WAS REPORTED.