BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 23378270 · Received October 24, 2025

    Report

    Report Number
    1710034-2025-01654
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    October 4, 2025
    Report Date
    December 23, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825448
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT THAT THE NEEDLE DOES NOT FULLY RETRACT WAS CONFIRMED AND THE CAUSE APPEARED TO BE MANUFACTURING RELATED. REPRESENTATIVE SAMPLES FROM LOT 5010456 WERE RECEIVED IN SEALED UNIT PACKAGES. A FUNCTIONAL TEST REVEALED THAT THE NEEDLES WERE PARTIALLY RETRACTED AND THE FLASH NOTCH ON 5 OF THE 20 TESTED UNITS BECAME CAUGHT ON THE BLOOD CONTROL VALVE UPON ACTIVATING THE SAFETY MECHANISM. THE DIMENSIONS OF THE NEEDLE WERE WITHIN SPECIFICATION. NO SLOW RETRACTION WAS IDENTIFIED ON THE REPRESENTATIVE SAMPLES. AS THE SAMPLES FROM SEALED UNIT PACKAGES FAILED TO FULLY RETRACT, THE COMPLAINT WAS CONFIRMED, AND THE CAUSE APPEARED TO BE MANUFACTURING RELATED. A NOTIFICATION OF THE CONFIRMED DEFECT WAS SENT TO OUR MANUFACTURING PERSONNEL FOR AWARENESS. 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. E1. ADDRESS INFORMATION WAS NOT PROVIDED; THEREFORE, (B)(6) WAS USED AS THE STATE.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Description of Event or Problem · 0

    UPON OPENING A FEW CATHETERS AND PRESSING THE WHITE BUTTON, I OBSERVED THAT THE NEEDLE DID NOT RETRACT FULLY AND WAS SLOW TO RETRACT HALFWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446097 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5010456 00382903825448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown