BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 21153443 · Received January 14, 2025

    Report

    Report Number
    1710034-2024-01607
    Event Type
    Malfunction
    Date Received
    January 14, 2025
    Date of Event
    December 26, 2024
    Report Date
    February 25, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    501

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    BATCH NUMBER UPDATED IN D TAB. INVESTIGATION RESULTS: THE COMPLAINT OF A LEAK WAS CONFIRMED, AND THE CAUSE APPEARED TO BE MANUFACTURING RELATED. EIGHT PHOTOGRAPHS AND ONE 22GA INSYTE AUTOGUARD UNIT FROM LOT: 4123601 WERE PROVIDED FOR INVESTIGATION. A FUNCTIONAL TEST OF THE RETURNED SAMPLE REVEALED A LEAK AT THE CONNECTION. A MICROSCOPIC EXAMINATION OF THE ADAPTER REVEALED AN AREA OF DEFORMATION ALONG THE INNER EDGE AT THE OPENING OF THE CATHETER ADAPTER. MATERIAL HAD BEEN PUSHED INSIDE THE LUER TAPER. THE EXTRA MATERIAL LIKELY PREVENTED A COMPLETE SEAL BETWEEN THE EXTENSION SET AND CATHETER ADAPTER. THE APPROPRIATE MANUFACTURING PERSONNEL WERE NOTIFIED OF THIS COMPLAINT. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD HAD A LOOSE CONNECTION AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: IT WAS REPORTED THAT THE INFUSION LINE COULD NOT BE CONNECTED (IT WAS LOOSE) RESULTING LEAKAGE. THE INFUSION LINE WAS LOOSE, AND THE LIQUID MEDICINE LEAKED OUT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2179806 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4123601 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown