WARMER DRAPE
Received Feb 29, 2016 · Event occurred Oct 1, 2015
Report 8043817-2016-00022 · MDR key 5467496
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Dominicana, S.a.Model number
ORS-320NLot number
SEE H10
Product problems
- Problem with Sterilization
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
NO ACTUAL PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION OR REVIEW. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS/REVIEW, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED. DHR WAS REVIEWED PRODUCT (B)(4), LOT D152231 AND IT WAS SEEN THAT THIS LOT HAD (B)(4) PIECES, AND IT WAS MANUFACTURED ON 08/20/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION.
Description of Event or Problem
END USER FOUND A SMALL HOLE ON THE WARMER SIDE OF THE DRAPE AND THE SOLUTION WAS NO LONGER STERILE. THIS WAS NOT REALIZED UNTIL AFTER THE CASE WAS OVER. THERE WERE NO PATIENT INJURY AND TREATMENT REPORTED OF THE INCIDENT.
Additional Manufacturer Narrative
NO ACTUAL PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION OR REVIEW. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS/REVIEW, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED. DHR WAS REVIEWED FOR PRODUCT ORS-300, LOT D152231 AND IT WAS SEEN THAT THIS LOT HAD (B)(4) PIECES, AND IT WAS MANUFACTURED ON 08/20/2015. FOLLOW UP #1: LOT 1036221 WAS REPORTED FOR THIS COMPLAINT. THIS IS THE STERILE LOT FROM MEDICAL ACTION WHICH CORRESPONDS TO THE MICROTEK NON STERILE LOTS D152161 AND D152221. THE DHR WAS REVIEWED FOR LOT D152161 AND IT WAS SEEN THAT THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 08/05/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION THE DHR WAS REVIEWED FOR LOT D152221 AND IT WAS SEEN THAT THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 08/11/2015. 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
END USER FOUND A SMALL HOLE ON THE WARMER SIDE OF THE DRAPE AND THE SOLUTION WAS NO LONGER STERILE. THIS WAS NOT REALIZED UNTIL AFTER THE CASE WAS OVER. THERE WERE NO PATIENT INJURY OR TREATMENT REPORTED FOR THE INCIDENT.