BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRAPE ARMOUR

    MDR report key: 6301447 · Received February 3, 2017

    Report

    Report Number
    8043817-2017-00003
    Event Type
    Malfunction
    Date Received
    February 3, 2017
    Report Date
    January 6, 2017
    Manufacturer
    MICROTEK DOMINICANA, S.A.
    Product Code
    KPY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83151 DRAPE ARMOUR RADIATION PROTECTION KPY MICROTEK DOMINICANA, S.A. RBFPS101L D160121

    Patients

    Seq Age Sex Outcome Treatment
    1