DRAPE ARMOUR
Received Feb 3, 2017
Report 8043817-2017-00003 · MDR key 6301447
Device
Generic name
Radiation Protection
Manufacturer
Microtek Dominicana, S.a.Model number
RBFPS101LLot number
D160121
Product problems
- Material Disintegration
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE DHR WAS REVIEWED FOR LOT D160121. THIS LOT HAD (B)(4) PCS AND WAS MANUFACTURED ON 01/14/2016 IN COMBINED SHIFT. NO DEFECTS RELATED TO THE NON CONFORMANCE WERE OBSERVED DURING THE QUALITY INSPECTION. BASED ON THE REVIEW OF THE DEVICE HISTORY RECORD, THE NON CONFORMITY DOESN'T APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS, OR MATERIALS ISSUE. NO SAMPLE WAS RECEIVED FOR EVALUATION.
Description of Event or Problem
CUSTOMER STATED THAT DURING A PROCEDURE THE DRAPE WAS SATURATED WITH BLOOD AND THEY WERE RUNNING A LINE BACK AND FORTH OVER THE PAD IN AND OUT OF THE FEMORAL ACCESS AND THE COVERING TO THE PAD DISINTEGRATED. THIS WAS CONSIDERED COMPROMISING TO PATIENT SAFETY. NO PATIENT INJURY OR TREATMENT WAS REPORTED FOR THE INCIDENT.