WARMER DRAPE
Received Jan 5, 2016 · Event occurred Nov 3, 2015
Report 8043817-2016-00001 · MDR key 5344009
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Dominicana, S.a.Model number
ORS-100NLot number
SEE H10
Product problems
- Hole In Material
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
NO PRODUCT HAS BEEN RETURNED. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED.
Description of Event or Problem
CUSTOMER REPORTS OF PIN HOLES IN A DRAPE WARMING 44X44 BNS P/N 5309009. THERE WERE NO PATIENT INJURY AND TREATMENT REPORTED OF THE INCIDENT.
Additional Manufacturer Narrative
NO PRODUCT HAS BEEN RETURNED. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED. FOLLOW UP #1: LOT 1036823 WAS REPORTED FOR THIS COMPLAINT. THIS IS THE STERILE LOT FROM MEDICAL ACTION WHICH CORRESPONDS TO THE FOLLOWING NON STERILE LOTS FROM MICROTEK: D152251A THE DEVICE HISTORY RECORD WAS REVIEWED FOR LOT D152251 AND IT WAS SEEN THAT THERE WERE NO DEFECTS REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTIONS. BASED ON THE DHR REVIEW THE NON CONFORMITY DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. DUE TO SAMPLE NOT BEING REVIEWED THE NON CONFORMITY COULD NOT BE PHYSICALLY CONFIRMED.
Description of Event or Problem
CUSTOMER REPORTS OF PIN HOLES IN A DRAPE WARMING DRAPE 44/44 BNS, P/N 5309009. THERE WERE NO PATIENT INJURY AND TREATMENT REPORTED FOR THE INCIDENT.