WARMER DRAPE

Additional Manufacturer Narrative

LOT D152501A, THIS LOT HAD 2,400 PCS AND IT WAS MANUFACTURED ON 09/08/15. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. BASED ON THE DHR REVIEW THE NON CONFORMITY DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. DUE TO RECEIVING NO SAMPLE THE NON CONFORMITY COULD NOT BE PHYSICALLY CONFIRMED. MELTS 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, CONTRARY TO THE OPERATIONS MANUAL, PRODUCT LABELING, PRODUCT INSERT AND IN-SERVICE PRESENTATIONS.

Description of Event or Problem

THE FLUID WARMER HAD A VERY SMALL HOLE IN THE DRAPE THAT WAS NOT DETECTED UNTIL THE SURGERY WAS COMPLETED. THE WAS USED AS PER USUAL WITH NO METAL OR SHARP OBJECTS PLACED IN THE BASIN. AFTER REMOVING THE DRAPE FROM THE WARMER, FLUID WAS SEEN IN THE BASIN SUGGESTING THE HOLE. THIS WAS ORIGINALLY REPORTED TO US ON A PRODUCT CONCERN FORM FROM (B)(6).

Additional Manufacturer Narrative

LOT D152501A, THIS LOT HAD (B)(4) AND IT WAS MANUFACTURED ON 09/08/15. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. BASED ON THE DHR REVIEW THE NON CONFORMITY DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. DUE TO RECEIVING NO SAMPLE THE NON CONFORMITY COULD NOT BE PHYSICALLY CONFIRMED. MELTS 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, CONTRARY TO THE OPERATIONS MANUAL, PRODUCT LABELING, PRODUCT INSERT AND IN-SERVICE PRESENTATIONS. FOLLOW UP #1: LOT 1042426 WAS REPORTED FOR THIS COMPLAINT. THIS IS THE STERILE LOT FROM MEDICAL ACTION WHICH CORRESPONDS TO THE MICROTEK NON STERILE LOTS D152501, D151761, D152031. THE DHR WAS REVIEWED FOR LOT D152501. THIS LOT HAD (B)(4) AND IT WAS MANUFACTURED ON 09/08/15. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D151761. THIS LOT HAD (B)(4) AND IT WAS MANUFACTURED ON 06/25/15. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D152031. THIS LOT HAD (B)(4) AND IT WAS MANUFACTURED ON 07/23/15. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. BASED ON THE DEVICE HISTORY RECORD THE DRAPE WAS MANUFACTURED TO SPECIFICATIONS AND THE NON CONFORMITY DOES NOT APPEAR TO BE THE RESULT OF A MATERIAL ISSUE. THE NON CONFORMITY COULD NOT BE CONFIRMED BECAUSE A SAMPLE WAS NOT RETURNED.

Description of Event or Problem

THE FLUID WARMER HAD A VERY SMALL HOLE IN THE DRAPE THAT WAS NOT DETECTED UNTIL THE SURGERY WAS COMPLETED. IT WAS USED AS PER USUAL WITH NO METAL OR SHARP OBJECTS PLACED IN THE BASIN. AFTER REMOVING THE DRAPE FROM THE WARMER, FLUID WAS SEEN IN THE BASIN SUGGESTING THE HOLE. THIS WAS ORIGINALLY REPORTED TO US ON A PRODUCT CONCERN FORM FROM PROVIDENCE HEALTH BC CANADA.

Additional Manufacturer Narrative

LOT D152501A, THIS LOT HAD 2400 PCS AND IT WAS MANUFACTURED ON 09/08/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. BASED ON THE DHR REVIEW THE NON CONFORMITY DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. DUE TO RECEIVING NO SAMPLE THE NON CONFORMITY COULD NOT BE PHYSICALLY CONFIRMED. MELTS 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, CONTRARY TO THE OPERATIONS MANUAL, PRODUCT LABELING, PRODUCT INSERT AND IN-SERVICE PRESENTATIONS. FOLLOW UP #1: LOT 1042426 WAS REPORTED FOR THIS COMPLAINT. THIS IS THE STERILE LOT FROM MEDICAL ACTION WHICH CORRESPONDS TO THE MICROTEK NON STERILE LOTS D152501, D151761, D152031. THE DHR WAS REVIEWED FOR LOT D152501. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 09/08/15. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D151761. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 06/25/15. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D152031. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 07/23/15. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. BASED ON THE DEVICE HISTORY RECORD THE DRAPE WAS MANUFACTURED TO SPECIFICATIONS AND THE NON CONFORMITY DOES NOT APPEAR TO BE THE RESULT OF A MATERIAL ISSUE. THE NON CONFORMITY COULD NOT BE CONFIRMED BECAUSE A SAMPLE WAS NOT RETURNED.

Description of Event or Problem

THE FLUID WARMER HAD A VERY SMALL HOLE IN THE DRAPE THAT WAS NOT DETECTED UNTIL THE SURGERY WAS COMPLETED. IT WAS USED AS PER USUAL WITH NO METAL OR SHARP OBJECTS PLACED IN THE BASIN. AFTER REMOVING THE DRAPE FROM THE WARMER, FLUID WAS SEEN IN THE BASIN SUGGESTING THE HOLE. THIS WAS ORIGINALLY REPORTED TO US ON A PRODUCT CONCERN FORM FROM (B)(6) .