BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOG BC

    MDR report key: 23129436 · Received September 23, 2025

    Report

    Report Number
    1710034-2025-01557
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    September 12, 2025
    Report Date
    October 22, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. YOUR REPORT OF NEEDLE RETRACTION ISSUES COULD NOT BE CONFIRMED FROM THE 13 REPRESENTATIVE 22G INSYTE AUTOGUARD UNITS THAT WERE RECEIVED IN SEALED PACKAGING FROM LOT #5092496. A FUNCTIONAL TEST REVEALED THAT EACH NEEDLE FULLY RETRACTED WITHOUT RESISTANCE OR DELAY WHEN THE SAFETY MECHANISM WAS ACTIVATED. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES 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 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

    INJURIES OR ADVERSE EVENT: NO REPORTED ISSUE: WE HAVE HAD ISSUES WITH OUR IV NEEDLES NOT RETRACTING WHEN WE HIT THE BUTTON FOR THE RELEASE. GENERALLY, WITH WIGGLING WE HAVE BEEN ABLE TO GET IT TO RETRACT. HOWEVER, TODAY WE COULD NOT GET IT TO RETRACT AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201619 INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5092496 00382903825233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown