ECOLAB

Description of Event or Problem

AVID MEDICAL IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY THAT CONTAINS A WARMER DRAPE PART # OEM-ORS-300N MANUFACTURED BY ECOLAB. AVID MEDICAL RECEIVED A COMPLAINT ON (B)(6)/2015 ORIGINATED BY (B)(6) MEDICAL CENTER STATING "ACCORDING TO STAFF, AT THE END OF A SURGICAL PROCEDURE, THE STERILE DRAPE WAS TAKEN OUT OF THE SOLUTION WARMER AND LIQUID WAS NOTED IN THE SOLUTION WARMER OUTSIDE OF THE DRAPE INDICATING THERE MAY HAVE BEEN A HOLE IN THE DRAPE. PHYSICIAN WAS NOTIFIED. TOTAL ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND PERITONEAL MEDIPORT PLACEMENT WAS THE PROCEDURE THAT WAS PERFORMED ON PATIENT WHEN LEAK IN DRAPE NOTED." AVID MEDICAL AND ECOLAB WERE BOTH NOTIFIED OF THIS COMPLAINT ON (B)(6) 2015 BY THE ORIGINATOR (B)(6) MEDICAL CENTER. AVID MEDICAL ISSUED FORMAL (B)(4) TO ECOLAB FOR LEAK IN THE WARMER DRAPE PART # OEM-ORS-300N, HOWEVER MS. (B)(6) WAS UNABLE TO PROVIDE A LOT #. NO FURTHER INFORMATION ON THE PATIENT IS AVAILABLE.