BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIODYNAMICS SOFT-VU OMNI FLUSH

    MDR report key: 1180469 · Received September 29, 2008

    Report

    Report Number
    MW5008481
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    September 26, 2008
    Report Date
    September 29, 2008
    Manufacturer
    ANGIODYNAMICS, INCORPORATED
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CATHETER FRACTURED INSIDE PT'S ARTERY AND THEN RETRIEVED. TIP BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIODYNAMICS SOFT-VU OMNI FLUSH ANGIOGRAPHIC CATHETER-4 FRENCH MSD ANGIODYNAMICS, INCORPORATED 903733

    Patients

    Seq Age Sex Outcome Treatment
    1