BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE-N AUTOGUARD

    MDR report key: 23376287 · Received October 24, 2025

    Report

    Report Number
    1710034-2025-01653
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    September 29, 2025
    Report Date
    November 7, 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
    CO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 381811 AND LOT NUMBER 5191878. 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

    IT WAS REPORTED THAT VENOUS ACCESS CANALIZATION PROCEDURE PERFORMED, INSYTE PERIPHERAL CATHETER NUMBER 24N USED, WHICH AT THE TIME OF THE SINGLE PUNCTURE, FLOWERED CATHETER TIP OBSERVED, CATHETER REMOVED. DUE TO CONTACT OF THE DEVICE WITH PATENT FLUIDS, IT IS NOT POSSIBLE TO SEND IT TO THE PHARMACY. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242493 INSYTE-N AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5191878 00382903818112

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown