BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASIX COMPAK INFLATION SYRINGE

    MDR report key: 2182395 · Received July 11, 2011

    Report

    Report Number
    9616662-2011-00043
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    May 12, 2011
    Report Date
    June 17, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K884913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE SUSPECT DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. A F/U REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. EVAL METHOD: DEVICE HISTORY RECORD WAS REVIEWED. CONCLUSIONS: A F/U REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY PROCEDURE IT WAS NOTICED THAT THE PRESSURE GAUGE DID NOT HAVE A COVER AND THE PRESSURE WAS WAVY DURING THE PROCEDURE. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BASIX COMPAK INFLATION SYRINGE INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT MERIT MEDICAL SYSTEMS, INC. K196315

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR PRESSURE EXTENSION TUBE