BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIDIAN

    MDR report key: 3912466 · Received May 22, 2014

    Report

    Report Number
    3912466
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 21, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS ATTEMPTING TO REMOVE INFERIOR VENA CAVA FILTER. THE FILTER WAS RETRIEVED ON THE FIRST PASS, BUT THE STABILIZING STRUT OR LEG WAS NOT CONNECTED AND REMAINED IN THE PATIENT. DECISION WAS MADE TO MAKE SECOND PASS AND SUCCESSFUL RETRIEVAL OF THE PART WHICH HAD BROKEN OFF WAS ACCOMPLISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306056 MERIDIAN FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK BARD PERIPHERAL VASCULAR, INC. MD800F GFXF3666

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR