BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD IV CATHETER

    MDR report key: 18676943 · Received February 9, 2024

    Report

    Report Number
    18676943
    Event Type
    Malfunction
    Date Received
    February 9, 2024
    Date of Event
    October 6, 2023
    Report Date
    October 11, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    INTRAVENOUS (IV) CATHETER WOULD NOT RETRACT NEEDLE WHEN BUTTON WAS PUSHED. IT WAS A 20 GA X 1.16 IN INSYTE AUTOGUARD IV CATHETER. LOT # 3192264.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68528 BD INSYTE AUTOGUARD IV CATHETER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ BECTON, DICKINSON AND COMPANY 381434 3192264

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female