BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE-N AUTOGUARD

    MDR report key: 23443153 · Received October 31, 2025

    Report

    Report Number
    1710034-2025-01718
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    October 14, 2025
    Report Date
    November 24, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814114
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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 381411 AND LOT NUMBER 5051385. 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

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    WHEN TRYING TO ADVANCE THE IV CATHETER, IT WOULD NOT MOVE. IV WAS PULLED AND THE PLASTIC CATHETER PIECE WAS FRAYED IN THE MIDDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1701415 INSYTE-N AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5051385 00382903814114

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown