BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 23745068 · Received December 8, 2025

    Report

    Report Number
    1710034-2025-01910
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    November 17, 2025
    Report Date
    January 2, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825233
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE SAMPLES FOR EVALUATION. YOUR REPORTED ISSUE THAT THE NEEDLE DOES NOT RETRACT COULD NOT BE CONFIRMED FROM THE REPRESENTATIVE 22GA INSYTE AUTOGUARD BC FROM LOT NUMBER 5142869 THAT WERE PROVIDED FOR INVESTIGATION. A FUNCTIONAL TEST SHOWED THAT THE NEEDLE FULLY RETRACTED WHEN THE SAFETY MECHANISM WAS ACTIVATED. NO DAMAGE OR DEFECTS THAT WOULD AFFECT NEEDLE RETRACTION WERE IDENTIFIED ON THE RETURNED SAMPLES. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    NEEDLE DOES NOT RETRACT. NO PATIENTS WERE HARMED AS THIS IS ONLY CODED AS A DEFECTIVE ITEM AND NOT AN ADVERSE.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130536 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5142869 00382903825233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown