ECOLAB

Description of Event or Problem

AVID MEDICAL IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY THAT CONTAINS A WARMER DRAPE PART # OEM-ORS-320 MANUFACTURED BY ECOLAB. AVID MEDICAL RECEIVED A COMPLAINT ON (B)(6) 2015 ORIGINATED BY (B)(6) HOSPITAL STATING "WARMER DRAPE THAT HELD SALINE / ANTIBIOTIC MIXTURE NOTED TO BE WET ON THE BOTTOM AFTER COMPLETION OF CASE. UPON INSPECTION TWO HOLES NOTED ON DRAPE. PHYSICIAN NOTIFIED, ADDITIONAL ANTIBIOTICS FOR PATIENT." AVID MEDICAL AND ECOLAB WERE BOTH NOTIFIED OF THIS COMPLAINT ON (B)(6) 2015 BY THE ORIGINATOR (B)(6). AVID MEDICAL ISSUED FORMAL (B)(4) TO ECOLAB ON (B)(6) 2015 FOR TWO HOLES IN ONE EACH SLUSH WARMER DRAPE PART # OEM-ORS-320. THE FOLLOWING WARMER DRAPE LOT #'S WERE USED TO BUILD AVID MEDICAL'S CUSTOM PROCEDURE TRAY D1518181RC, D151611RC, D151941RC, D151331RC, D152221RC, D151451RC, D151351RC, D152161RC, D151601RC. NO FURTHER INFORMATION ON THE PATIENT IS AVAILABLE.