BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE-N AUTOGUARD

    MDR report key: 22925951 · Received August 29, 2025

    Report

    Report Number
    1710034-2025-01407
    Event Type
    Malfunction
    Date Received
    August 29, 2025
    Date of Event
    August 12, 2025
    Report Date
    October 9, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818112
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE SAMPLES FOR EVALUATION. YOUR REPORT OF NEEDLE RETRACTION FAILURE COULD NOT BE CONFIRMED FROM THE 18 REPRESENTATIVE 24G INSYTE AUTOGUARD UNITS THAT WERE RECEIVED IN SEALED PACKAGING FROM LOT #3262520. A FUNCTIONAL TEST OF THE RETURNED SAMPLES REVEALED NO DAMAGE OR DEFECTS. EACH SAMPLE FULLY RETRACTED WHEN THE SAFETY MECHANISM WAS ACTIVATED AND THE RETRACTION TIME WAS WITHIN SPECIFICATION. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    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

    THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER IN RESPONSE TO INVESTIGATION FINDINGS RELATED TO SLOW NEEDLE RETRACTION WHERE THE FAILURE COULD NOT BE REPRODUCED WITH THE PROVIDED SAMPLES: "THIS MORNING AFTER READING YOUR LETTER OF FINDING, WE REPRODUCED THE INCIDENT SIX TIMES! WE ARE REQUESTING THAT THIS BE REVISITED.". ADDITIONAL INFORMATION ON 8/26/2025: HI, YES, THE REENACTMENT WAS COMPLETED WITH THE SAME LOT #.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2163574 INSYTE-N AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3262520 00382903818112

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown