WARMER DRAPE

Additional Manufacturer Narrative

BASED ON THE REVIEW OF THE DEVICE HISTORY RECORD, THE NON CONFORMITY DOESN'T APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIALS ISSUE. SINCE A SAMPLE WAS NOT REVIEWED, THE NON CONFORMITY COULD NOT BE CONFIRMED. MELTS, THOUGH UNCOMMON, CAN OCCUR WHEN THE WARMER IS NOT DRAPED PROPERLY, NOT TURNED OFF BY USING THE POWER BUTTON, AND/OR THERE IS INSUFFICIENT FLUID IN THE WARMER BASIN; AND/OR IF THE WARMER IS OPERATED CONTRARY TO THE OPERATIONS MANUAL, PRODUCT LABELING, PRODUCT INSERT AND IN-SERVICE PRESENTATIONS.

Description of Event or Problem

AN END USER REPORT OF LEAKS ON WARMER DRAPE ORS-300, 44 X 4, NOTICED WHEN DRAPES WERE BEING REMOVED FROM THE SOLUTION WARMERS. THERE WERE NO PATIENT INJURY AND TREATMENT REPORTED OF THE INCIDENT.

Additional Manufacturer Narrative

BASED ON THE REVIEW OF THE DEVICE HISTORY RECORD, THE NON CONFORMITY DOESN'T APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS, OR MATERIALS ISSUE. SINCE A SAMPLE WAS NOT REVIEWED, THE NON CONFORMITY COULD NOT BE CONFIRMED. MELTS, THOUGH UNCOMMON, CAN OCCUR WHEN THE WARMER IS NOT DRAPED PROPERLY, NOT TURNED OFF BY USING THE POWER BUTTON, AND/OR THERE IS INSUFFICIENT FLUID IN THE WARMER BASIN; AND/OR IF THE WARMER IS OPERATED CONTRARY TO THE OPERATIONS MANUAL, PRODUCT LABELING, PRODUCT INSERT AND IN-SERVICE PRESENTATIONS. FOLLOW UP #1: LOT 1040518 WAS REPORTED FOR THIS COMPLAINT. THIS IS THE STERILE LOT FROM MEDICAL ACTION WHICH CORRESPONDS TO THE MICROTEK NON STERILE LOTS D151941, D151671, D151661, D151731, D151821. THE DHR WAS REVIEWED FOR LOT D151941 AND IT WAS SEEN THAT THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 10/28/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D151671 AND IT WAS SEEN THAT THIS LOT HAD (B)(4) PCS AND WAS REPACKAGED ON 9/30/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D151661 AND IT WAS SEEN THAT THIS LOT HAD (B)(4) PCS AND WAS REPACKAGED ON 10/27/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D151731 AND IT WAS SEEN THAT THIS LOT HAD (B)(4) PCS AND WAS REPACKAGED ON 10/24/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D151821 AND IT WAS SEEN THAT THIS LOT HAD (B)(4) PCS AND WAS REPACKAGED ON 10/29/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. BASED ON THE DHR REVIEW, THIS DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. THE NON CONFORMITY COULD NOT BE CONFIRMED BECAUSE A SAMPLE WAS NOT RETURNED.

Description of Event or Problem

CUSTOMER REPORTED LEAKS IN DRAPE. NO PATIENT INJURY OR TREATMENT WERE REPORTED FOR THE INCIDENT.