BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JELCO

    MDR report key: 99616 · Received June 20, 1997

    Report

    Report Number
    99616
    Event Type
    Malfunction
    Date Received
    June 20, 1997
    Date of Event
    May 22, 1997
    Report Date
    May 30, 1997
    Manufacturer
    J & J MEDICAL
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE STARTING IV WITH 20G 1 1/4" JELCO, THE CANNULA HUB BROKE OFF OUTER CANNULA WHEN INNER CANNULA WAS WITHDRAWN. OUTER CANNULA PULLED OUT ALSO, ALL PARTS WERE ACCOUNTED FOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JELCO IV CATHETER 20G 1 1/2 FOZ J & J MEDICAL * 0437K51

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other