WARMER DRAPE
Received Feb 26, 2016
Report 8043817-2016-00021 · MDR key 5463405
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Dominicana, S.a.Model number
ORS-320NLot number
SEE H10
Product problems
- Leak/Splash
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
NO 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.
Description of Event or Problem
END USER INFORMED OF A LEAKING DRAPE WARMER 44 X 66, FOUND DURING SET UP. THERE WERE NO PATIENT INJURY AND TREATMENT REPORTED OF THE INCIDENT.
Additional Manufacturer Narrative
NO PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION OR REVIEW. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS OR REVIEW THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED. LOT 1042717 WAS REPORTED FOR THIS COMPLAINT. THIS IS THE STERILE LOT FROM MEDICAL ACTION WHICH CORRESPONDS TO THE MICROTEK NON STERILE LOTS D151351, D15611, D152541, D152641, D151611, D152581 AND D151671. THE DHR WAS REVIEWED FOR LOT D152641. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 09/21/15. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D152541. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 09/11/15. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D151611. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 06/10/15. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D152221. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 08/11/15. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D152161. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 08/05/15. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D152581. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 09/18/15. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D151671. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 06/16/15. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D151351. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 05/18/15. 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
END USER REPORTED A LEAKING DRAPE WARMER 44 X 66 FOUND DURING SET UP. THERE WERE NO PATIENT INJURY OR TREATMENTS REPORTED FOR THE INCIDENT.