BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE-N AUTOGUARD

    MDR report key: 25243833 · Received May 21, 2026

    Report

    Report Number
    1710034-2026-00547
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    May 1, 2026
    Report Date
    May 26, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903815111
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G.4. K201075; K251654 H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    IT IS REPORTED THAT NEEDLE RETRACTION ISSUES ARE LEADING TO NEEDLE PIERCING THE CATHETER. STAFF STATE IT IS DRAGGING AND IF THEY HAVE TO PULL OUT A BIT AT ALL IT PUNCTURES THE PLASTIC PART. THEY SAID THE BABIES ARE BEING STUCK MULTIPLE TIMES DUE TO THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276489 INSYTE-N AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5210670 00382903815111

    Patients

    Seq Age Sex Outcome Treatment
    1