BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASIX COMPAK INFLATION SYRINGE

    MDR report key: 2059132 · Received March 11, 2011

    Report

    Report Number
    9616662-2011-00017
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 11, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DTL
    PMA / PMN Number
    K993057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS NOT BEEN REC'D FOR EVALUATION. A F/U REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    WHILE INJECTING THROUGH THE HEMOSTASIS DEVICE THE ROTATOR CAME APART. NO CLINICAL STAFF WERE SPRAYED. THIS IS THE THIRD TIME THIS HAS HAPPENED RECENTLY. NO SPECIFIC DETAILS ARE AVAILABLE FOR THE ADDITIONAL TWO EVENTS. NO PT HARM OR INJURY WAS REPORTED. THIS IS ONE OF THREE REPORTS FOR THIS COMPLAINT. 961662-2011-00018, 961662-2011-00019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BASIX COMPAK INFLATION SYRINGE INJECTOR AND SYRINGE, ANGIOGRAPHIC DTL MERIT MEDICAL SYSTEMS, INC. K114839

    Patients

    Seq Age Sex Outcome Treatment
    1