BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 24604352 · Received March 16, 2026

    Report

    Report Number
    24604352
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    December 10, 2025
    Report Date
    March 11, 2026
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    REPORTED ISSUES WITH THE INSYTE AUTOGUARD IV CATHETER LOT NUMBER: 5191871 EXP: 06/30/2028, ISSUES HAVE INCLUDED: NOT RETRACTING AFTER PUSHING THE BUTTON, RETRACTING BEFORE THE BUTTON IS PUSHED, AND IV CATHETER NOT ADVANCING AFTER NEEDLE HAS BEEN INTRODUCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663335 BD INSYTE AUTOGUARD CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ BECTON, DICKINSON AND COMPANY 5191871

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other