BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYURETHANE, FLEXIBLE BRAIDED TUBING

    MDR report key: 2202324 · Received August 5, 2011

    Report

    Report Number
    1721504-2011-00238
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DXJ
    PMA / PMN Number
    K883718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: NO SUSPECT DEVICES ARE EXPECTED TO BE RETURNED FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. THE CUSTOMER DID NOT SPECIFY IF THIS WAS THE INITIAL USE OF THE DEVICE. BASED OFF OF SIMILAR COMPLAINTS IT IS SUSPECTED THAT THE ROTATOR MAY SEPARATE AT THE BOND BETWEEN THE COLLAR AND THE HOUSING. THE ROOT CAUSES OF THE FAILURE ARE ATTRIBUTED TO THE MFG BONDING PROCESS. CORRECTION ACTIONS HAVE BEEN IMPLEMENTED TO ADDRESS THIS TYPED OF FAILURE. THIS LOT WAS BUILT PRIOR TO IMPLEMENTATION OF THE NOTED CORRECTIVE ACTIONS. EVAL: METHOD: EVAL BASED OFF OF SIMILAR COMPLAINTS, DEVICE HISTORY RECORD WAS REVIEWED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ROTATOR BROKE DURING USE AT 900 PSI WHILE CONNECTED TO AN ARTERIAL CATHETER. NO HARM OR INJURY WAS REPORTED. THE CUSTOMER REPORTED THAT THIS OCCURRED TWICE. HOWEVER, NO ADD'L INFO OR CLINICAL DETAILS WERE PROVIDED BY THE CUSTOMER FOR THE SECOND EVENT. THE CUSTOMER IS ALSO NOT EXPECTED TO RETURN ANY DEVICES FOR EVAL. THEREFORE, THIS SINGLE FORM FDA 3500A WILL BE SUBMITTED FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYURETHANE, FLEXIBLE BRAIDED TUBING DISPLAY, CATHODE RAY-TUBE, MEDICAL DXJ MERIT MEDICAL SYSTEMS, INC. F719695

    Patients

    Seq Age Sex Outcome Treatment
    1 ARTERIAL CATHETER