BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIDIAN FILTER SYSTEM

    MDR report key: 2943303 · Received December 13, 2012

    Report

    Report Number
    2020394-2012-00286
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 20, 2012
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SCHEDULED VENA CAVA FILTER RETRIEVAL APPROX FIVE MONTHS POST FILTER IMPLANT, A DETACHED LIMB WAS DISCOVERED EMBEDDED IN THE IVC WALL. THE FILTER AND DETACHED LIMB WERE RETRIEVED SUCCESSFULLY WITHOUT INCIDENT. NO REPORTED PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1