BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIDIAN FILTER SYSTEM = FEMORAL

    MDR report key: 2843713 · Received October 26, 2012

    Report

    Report Number
    2020394-2012-00241
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    September 20, 2012
    Report Date
    October 4, 2012
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K112497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER HAS BEEN PROVIDED AND THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SCHEDULED RETRIEVAL OF AN IVC FILTER, IT WAS DISCOVERED THAT A DETACHED LIMB WAS EMBEDDED IN THE IVC WALL. THE FILTER AND DETACHED LIMB WERE SUCCESSFULLY REMOVED WITHOUT INCIDENT. THERE IS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIDIAN FILTER SYSTEM = FEMORAL DTK BARD PERIPHERAL VASCULAR, INC. GFWA0045

    Patients

    Seq Age Sex Outcome Treatment
    1