BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 23745072 · Received December 8, 2025

    Report

    Report Number
    1710034-2025-01909
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    November 17, 2025
    Report Date
    December 23, 2025
    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

    THE COMPLAINT OF NEEDLE RETRACTION ISSUES COULD NOT BE CONFIRMED FROM THE REPRESENTATIVE 22G INSYTE AUTOGUARD UNITS THAT WERE RECEIVED IN SEALED PACKAGING FROM LOT #5142869. A FUNCTIONAL TEST REVEALED THAT THE NEEDLES FULLY RETRACTED WITHOUT RESISTANCE OR DELAY WHEN THE SAFETY MECHANISM WAS ACTIVATED. A REVIEW OF THE INSPECTION RECORDS AND QUALITY/MANUFACTURING CONTROLS FOR THE IMPLICATED LOT INDICATED NO ISSUES WITH THE MANUFACTURING PROCESS. ALTHOUGH THE REPORTED ISSUE COULD NOT BE CONFIRMED, THE COMPLAINT HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED AS PART OF ONGOING EFFORTS TO IDENTIFY POTENTIAL MANUFACTURING RELATED ISSUES. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY.

    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.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154582 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5142869 00382903825233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown