BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 22853449 · Received August 20, 2025

    Report

    Report Number
    1710034-2025-01388
    Event Type
    Malfunction
    Date Received
    August 20, 2025
    Date of Event
    August 7, 2025
    Report Date
    October 6, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903815449
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPHS SUBMITTED FOR EVALUATION. YOUR REPORT OF PREMATURE NEEDLE RETRACTION COULD NOT BE CONFIRMED FROM THE PHOTOGRAPHS THAT WERE PROVIDED FOR INVESTIGATION. THE PHOTOS SHOW THE LABELING AND PACKAGING FOR 18G INSYTE AUTOGUARD DEVICES FROM LOT #4150601. THE ACTUAL DEVICES AND NEEDLES WERE NOT VISIBLE IN THE PHOTOGRAPHS. NO OTHER SIMILAR COMPLAINTS WERE REPORTED FROM OTHER CUSTOMERS FOR THE IMPLICATED LOT. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE ACTUAL PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE REPORTED ISSUE WAS THAT THE NEEDLE IS PREMATURELY RETRACTING WHILE STILL ADVANCING THE UNIT INTO THE VEIN CAUSING A POTENTIAL BLOOD EXPOSURE.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295453 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4150601 00382903815449

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown