BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOS OMNI II

    MDR report key: 587486 · Received March 29, 2005

    Report

    Report Number
    1319211-2005-00012
    Event Type
    Malfunction
    Date Received
    March 29, 2005
    Date of Event
    February 5, 2005
    Report Date
    March 29, 2005
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADVANCED SOS OMNI TI THROUGH 5F SHEATH -FLUORO INDICATED TIP OF CATHETER WAS ABSENT. WITHDREW CATHETER FROM PT. FOUND TIP OF CATHETER ON DRAPES. OPENED 2 MORE CATHETERS OF SAME EXPIRATION DATE (2005/03) TIPS BRITTLE, SNAPPED OFF EASILY IN PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOS OMNI II ANGIOGRAPHIC CATHETER DQO ANGIODYNAMICS, INC. * 549327

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR