BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 22654262 · Received July 29, 2025

    Report

    Report Number
    1710034-2025-01250
    Event Type
    Malfunction
    Date Received
    July 29, 2025
    Date of Event
    June 14, 2025
    Report Date
    September 15, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814336
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    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

    OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPH AND SAMPLE SUBMITTED FOR EVALUATION. YOUR REPORT OF A DEFECTIVE NEEDLE WAS CONFIRMED AND THE CAUSE APPEARED TO BE MANUFACTURING RELATED. ONE PHOTOGRAPH AND ONE 20G INSYTE AUTOGUARD DEVICE FROM LOT #5092492 WERE PROVIDED FOR INVESTIGATION. THE LOT NUMBER OF THE DEVICE IN THE PHOTOGRAPH COULD NOT BE DETERMINED. THE NEEDLE WAS NOT BROKEN; HOWEVER, THE REMAINING WALL THICKNESS AT THE NOTCH IN THE NEEDLE WAS BELOW SPECIFICATION. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE LOOKING LIKE IT COULD BREAK OFF.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1383714 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5010459 00382903814336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown