BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 25323313 · Received May 28, 2026

    Report

    Report Number
    1710034-2026-00563
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    May 11, 2026
    Report Date
    May 13, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903826230
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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.

    Description of Event or Problem · 0

    WHEN NS FLUSH WAS CONNECTED TO IV CATHLON, THERE WAS LEAKAGE AT THE CONNECTION SITE. ATTEMPTED TO DISCONNECT AND RE-CONNECT BUT WAS UNABLE TO HAVE SEALED CONNECTION WHEN PUSHING FLUIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514934 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5339236 00382903826230

    Patients

    Seq Age Sex Outcome Treatment
    1