BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHIELDED INSYTE AUTOGUARD

    MDR report key: 1053102 · Received May 16, 2008

    Report

    Report Number
    1053102
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Date of Event
    May 8, 2008
    Report Date
    May 16, 2008
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING AN IV INSERTION, IT WAS NOTED THAT THE END OF THE PLASTIC CANNULA WAS CRACKED. THE TIP WAS IN ONE PIECE, BUT DID NOT ALLOW FOR SUCCESSFUL THREADING OF THE CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHIELDED INSYTE AUTOGUARD CATHETER, IV FOZ BECTON DICKINSON * 7305560

    Patients

    Seq Age Sex Outcome Treatment
    1 *