BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIO-JET ULTRA CATH

    MDR report key: 1404655 · Received June 17, 2009

    Report

    Report Number
    MW5011567
    Event Type
    Malfunction
    Date Received
    June 17, 2009
    Date of Event
    May 15, 2009
    Report Date
    May 19, 2009
    Manufacturer
    POSSIS
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CATH WAS PUNCTURED NEAR HUB. IT WAS INTRODUCING AIR AND CREATED LOSS OF VACUUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-JET ULTRA CATH NONE FOZ POSSIS 106552-001 92030

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR