BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 25307137 · Received May 27, 2026

    Report

    Report Number
    1710034-2026-00558
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    May 7, 2026
    Report Date
    May 12, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825233
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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

    IT IS REPORTED THAT LEAKAGE OCCURS. ITEM LEAKS FROM THE SIDE ONCE THE NURSE INSERTS THE IV CATH INTO THE PATIENT, THERE ARE NO REPORTED INJURIES OTHER THAT THE DEFECTIVE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429198 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5233517 00382903825233

    Patients

    Seq Age Sex Outcome Treatment
    1