BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD

    MDR report key: 2940815 · Received March 22, 2006

    Report

    Report Number
    2940815
    Event Type
    Malfunction
    Date Received
    March 22, 2006
    Date of Event
    March 16, 2006
    Report Date
    March 17, 2006
    Manufacturer
    BARD P.V.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    "TRYING TO DEPLOY A BARD INC FILTER G2 LOT #GFPH4490. THE FILTER WOULD NOT COMPLETELY EXIST THE SHEATH. AFTER MUCH MANIPULATION THE FILTER PIO RELEASE. UPON THE SHEATH REGIONAL THE DELIVERY SHEATH SEPARATED WITH A 4MM PISTAL PIECE OF SHEATH BEING LEFT IN THE PT. THE PIECE MIGRATED TO THE LEFT LUNG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD VENA CAVAL FILTER DTK BARD P.V. G-Z AF - 310F GFPH4490

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other