BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD BC

    MDR report key: 24617080 · Received March 17, 2026

    Report

    Report Number
    MW5185289
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    March 9, 2026
    Report Date
    March 10, 2026
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BD INSYTE AUTOGUARD BC IV NEEDLE DID NOT RETRACT UPON INSERTION. NEEDLE WAS CAREFULLY REMOVED AND WHEN NEEDLE WAS COMPLETELY FREE, RETRACTED BY ITSELF. IT DID NOT AFFECT PLASTIC CATHETER, BLOW VEIN, INJURE PATIENT. ALTHOUGH THERE WAS NO HARM NOTED TO THE PATIENT, THE NEEDLE HAD TO BE MANUALLY RETRACTED AND THUS THERE WAS A RISK FOR INJURY TO THE USER/NURSE INSERTING THE IV. WE HAVE IDENTIFIED A TREND WITH THIS ISSUE/LOT NUMBER LOT 6020809.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682258 BD INSYTE AUTOGUARD BC CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON 6020809

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Other