BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 23478998 · Received November 5, 2025

    Report

    Report Number
    1710034-2025-01732
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    October 16, 2025
    Report Date
    November 25, 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
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. YOUR REPORTED ISSUE THAT THE NEEDLE IS NOT RETRACTING CORRECTLY WAS CONFIRMED AND THE CAUSE APPEARED TO BE MANUFACTURING RELATED. REPRESENTATIVE UNITS FROM LOTS 5030829, 5171717, AND 5120110 WERE PROVIDED FOR INVESTIGATION. A FUNCTIONAL TEST SHOWED THAT THE NEEDLE ON SOME UNITS FROM LOTS 5030829 AND 5171717 FAILED TO FULLY RETRACT WITHIN THE SAFETY SHIELD. THE NOTCH IN THE NEEDLE APPEARED TO CATCH ON THE BLOOD CONTROL VALVE. FOR LOT #5120110, THE NEEDLE RETRACTION TIME OF SOME UNITS EXCEEDED THE SPECIFICATION. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THESE BATCHES. HOWEVER, A TREND WAS IDENTIFIED FOR THE REPORTED FAILURE AND CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTIFY THE ROOT CAUSE.

    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

    DELAYED NEEDLE RETRACTION AFTER BUTTON DEPRESSED INCREASING POTENTIAL NEEDLE SICK INJURY. SEVERITY LEVEL (REPORTED)- UNKNOWN. INJYR INCURRED? UNSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2465214 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5120110 00382903825448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown