WARMER DRAPE
Received Apr 12, 2016
Report 8043817-2016-00029 · MDR key 5569847
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Dominicana, S.a.Model number
ORS-300NLot number
SEE H10
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DHR WAS REVIEWED AND IT WAS SEEN THAT THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 7/10/2015. NO DEFECT WAS REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS/REVIEW, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED.
Description of Event or Problem
AN END USER FOUND HOLD IN DRAPE. NOTICED AT THE END OF A CASE. THERE WERE NO PATIENT INJURY AND TREATMENT REPORTED OF THE INCIDENT.
Additional Manufacturer Narrative
DHR WAS REVIEWED AND IT WAS SEEN THAT THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 7/10/2015. NO DEFECT WAS REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS/REVIEW, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED. FOLLOW UP #1 LOT 1048190 WAS REPORTED IN THIS COMPLAINT. THIS IS THE STERILE LOT FROM MEDICAL ACTION WHICH CORRESPONDS TO MICROTEK NONSTERILE LOTS D152781 AND D152751. THE DHR WAS REVIEWED FOR LOT D152781 AND IT WAS SEEN THAT THIS LOT HAD (B)(4) PCS AND WAS MANUFACTURED ON 10/5/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D152751 AND IT WAS SEEN THAT THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 10/2/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. BASED ON THE DHR REVIEW, 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
AN END USER FOUND HOLE IN DRAPE. NOTICED AT THE END OF A CASE. THERE WERE NO PATIENT INJURY AND TREATMENT REPORTED OF THE INCIDENT.