BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 23386524 · Received October 24, 2025

    Report

    Report Number
    1710034-2025-01658
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    April 17, 2024
    Report Date
    October 27, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: REPORTING AWARENESS DATE (DATE RECEIVED BE THE MFG) IS THE DATE OF THE INVESTIGATION CLOSURE. DATE HAS BEEN CORRECTED.

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE SAMPLE FOR EVALUATION. YOUR REPORT OF NEEDLE RETRACTION FAILURE WAS CONFIRMED, AND THE CAUSE WAS DETERMINED TO BE MANUFACTURING RELATED. ONE 22GA INSYTE AUTOGUARD UNIT FROM LOT NUMBER: 3251086 WAS PROVIDED FOR INVESTIGATION. THE NEEDLE WAS RECEIVED FULLY EXTENDED FROM THE SHIELD. ADHESIVE WAS FOUND BETWEEN THE NEEDLE HUB AND THE GRIP, WHICH PREVENTED NEEDLE RETRACTION. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCE'S ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. HOWEVER, A TREND WAS IDENTIFIED FOR THE REPORTED FAILURE AND CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTITY THE ROOT CAUSE. THE APPROPRIATE MANUFACTURING PERSONNEL WERE NOTIFIED OF THIS COMPLAINT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    HARD NEEDLES CANNOT BE RECYCLED NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2217192 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3251086 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown