BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 23610704 · Received November 20, 2025

    Report

    Report Number
    1710034-2025-01828
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Date of Event
    August 1, 2025
    Report Date
    December 2, 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
    IL, 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 NUMBER 5052305. 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

    (B)(6) 2025: WHEN STARTING AN IV, BLOOD RETURN (FLASH) WAS OBTAINED IN THE CATHETER, AND THE CATHETER WAS BEING TREADED INTO THE VEIN. THE BUTTON TO RETRACT THE NEEDLE WAS THEN PUSHED AND IT PULLED THE CATHETER OUT OF THE VEIN AND IT SHOT IT ACROSS THE ROOM. IT SEEMED THAT THE CATHETER HUB WAS STUCK TO THE NEEDLE OR SPRING-LOADED PLASTIC THAT RETRACTS THE NEEDLE. THE PATIENT THEN STARTED BLEEDING, AND BLOOD WAS ALSO ON THE BED, WALL, FLOOR, AND NURSE. THE PATIENT ALSO HAD TO BE STUCK AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314398 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5052305 00382903825349

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown