BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 25154226 · Received May 12, 2026

    Report

    Report Number
    1710034-2026-00507
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    April 24, 2026
    Report Date
    April 28, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825127
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G.4. K201075; K251654.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON A NEEDLE. A NURSE WAS ABOUT TO START AN IV ON A PATIENT AND UNCAPPED THE NEEDLE TO SEE ¿SOMETHING DARK¿ ATTACHED TO THE NEEDLE TIP. MAY EVEN BE A BUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341640 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5219750 00382903825127

    Patients

    Seq Age Sex Outcome Treatment
    1