BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMOD EZ PACK

    MDR report key: 97296 · Received June 11, 1997

    Report

    Report Number
    MW1011448
    Event Type
    Malfunction
    Date Received
    June 11, 1997
    Date of Event
    May 13, 1997
    Report Date
    June 2, 1997
    Manufacturer
    USCI DIV., C.R. BARD, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    6F USCI PIGTAIL CATHETER WITH HOLE IN IT. OMNIPAQUE SPRAYED OVER SCRUB NURSE & PHYSICIAN FROM MEDRAD POWER INJECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARMOD EZ PACK PIGTAIL CATHETER DQO USCI DIV., C.R. BARD, INC. * 08AH1290

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other