WARMER DRAPE

Additional Manufacturer Narrative

AN INVESTIGATION IS COMPLETED AT THE MFG SITE IN THE (B)(4). BASED ON THE DHR REVIEWED, THIS LOT HAD (B)(4) PIECES AND IT WAS MANUFACTURED ON 12/09/2013. NO DEFECTS WERE REPORTED DURING PROCESSING, PACKAGING OR FINAL INSPECTION. THE INVESTIGATION REVEALED THAT THIS PROBLEM WAS NOT DUE TO AN ASSEMBLY, MATERIAL, OR PROCESS ISSUE. (B)(4)'S COMPLAINT DEPT. HAS CONTACTED (EMAIL AND CALLED) THE USER FACILITY, (B)(6), THREE TIMES PER THE FOLLOWING DATES: (B)(4) 2015. THERE HAS BEEN NO RESPONSE FROM THE USER FACILITY TO THE (B)(4) COMPLAINT DEPT. NO PRODUCT HAS BEEN RETURNED. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED.

Description of Event or Problem

THERE WAS A REPORT FORM THE USER FACILITY (UF/IMPORTER REPORT#: (B)(4)), (B)(6). THAT REPORT WAS SENT TO (B)(4); RECEIVED (B)(4) 2014. PRODUCT#: ORS-100, WARMER DRAPES, HAD BEEN FOUND LEAKING. UPON TAKING THE IRRIGATION DRAPE OUT OF THE FLUID WARMER AT THE END OF PROCEDURE, A PIN HOLE WAS NOTED IN THE DRAPE. SALINE IRRIGATION WAS LEAKING THROUGH. THE NURSE ANESTHETIST (CRNA) RE-DOSED THE PATIENT WITH 1 GRAM OF CEFAZOLIN AT THE END OF THE PROCEDURE. L KNEE ACL RECONSTRUCTION WAS THE INTENDED PROCEDURE.