BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 21656035 · Received March 20, 2025

    Report

    Report Number
    1710034-2025-00439
    Event Type
    Malfunction
    Date Received
    March 20, 2025
    Date of Event
    March 3, 2025
    Report Date
    May 7, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818341
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE 20 GA X 1.16 IN. INSYTE AUTOGUARD UNIT FROM LOT NUMBER 4193356. YOUR REPORT OF RETRACTION ISSUES WAS CONFIRMED BASED ON THE CONDITION OF THE SPRING COMPONENT OF THE SAFETY MECHANISM. THE UNIT WAS RECEIVED FULLY RETRACTED AND WITH MEDIA. NO CATHETER WAS PROVIDED. MICROSCOPIC ANALYSIS DISCOVERED THAT THE SPRING APPEARED TO BE ON THE NEEDLE HUB. DURING MANUFACTURING WHEN THE HUBS ARE LOADED INTO THE GRIPS, MACHINE MISALIGNMENT MAY CAUSE DAMAGE TO THE HUB OR THE SPRING. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Additional Manufacturer Narrative · 0

    STREET ADDRESS EXCEEDS CHARACTERS LIMIT: NO. (B)(6). 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 ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: SAFETY MECHANISM CAN¿T RETRACT THE SAFETY MECHANISM CANNOT BE RETRACTED AND THERE IS A RISK OF NEEDLESTICKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537875 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4193356 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown