BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 21235754 · Received January 24, 2025

    Report

    Report Number
    1710034-2025-00070
    Event Type
    Malfunction
    Date Received
    January 24, 2025
    Date of Event
    January 8, 2025
    Report Date
    June 16, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814237
    PMA / PMN Number
    K201075
    Removal / Correction Number
    MDS-25-5274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE REPRESENTATIVE SAMPLES SENT FOR EVALUATION. BD RECEIVED 348 SEALED 22GA X 1.00IN. INSYTE AUTOGUARD UNITS FROM LOT NUMBER 4229661. A SAMPLING OF 20 UNITS WERE RANDOMLY SELECTED FOR INVESTIGATION. THE UNITS WERE INSPECTED BY BREAKING TIP ADHESION, SLIGHTLY ADVANCING THE CATHETER, AND ACTIVATING THE BUTTON. A FUNCTIONAL TEST SHOWED THAT THE RETRACTION TIME EXCEEDED THE SPECIFICATION ON SOME OF THE UNITS. YOUR REPORTED ISSUE WAS CONFIRMED AND DETERMINED TO BE MANUFACTURING RELATED. DURING MANUFACTURING, GEL IS INSERTED INTO THE SPRING CAVITY. EXCESSIVE GEL MAY RESULT IN A SLOW RETRACTION. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. HOWEVER, A TREND HAS BEEN IDENTIFIED FOR THE REPORTED FAILURE AND CORRECTIVE ACTIONS HAVE BEEN INITIATED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTITY THE ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION OF FA#.

    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. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E1. ADDRESS INFORMATION WAS NOT PROVIDED, THEREFORE, XX WAS USED AS A PLACE HOLDER.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE WAS SLOW TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAFETY FEATURE OF NEEDLE TAKING TOO LONG TO RETRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2404626 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4229661 00382903814237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown