BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 23386573 · Received October 24, 2025

    Report

    Report Number
    1710034-2025-01662
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    October 2, 2025
    Report Date
    October 30, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825349
    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

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 382534 AND LOT NUMBERS 5135741, 5045781 AND 4193407. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE, AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    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

    PT HERE FOR SURGERY. HAVING PIV PLACED BY HEATH TECH. WHILE PLACING THE PIV, SHE HAD GREAT BLOOD RETURN. WHILE SLIDING THE CATHETER OFF OF THE NEEDLE, THE NEEDLE POKED THROUGH THE CATHETER. SHE THEN REMOVED BOTH THE CATHETER AND THE NEEDLE. CATHETER NOTED TO BE INTACT BELOW THE LEVEL OF THE HOLE. WITH NEEDLE GOING THROUGH THE SHEATH, ANOTHER VEIN COULD HAVE BEEN PUNCTURED OR CAUSED DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2173176 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5135741 00382903825349

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown