BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 21315737 · Received February 5, 2025

    Report

    Report Number
    1710034-2025-00119
    Event Type
    Malfunction
    Date Received
    February 5, 2025
    Date of Event
    January 13, 2025
    Report Date
    June 16, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814336
    PMA / PMN Number
    K201075
    Removal / Correction Number
    MDS-25-5274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE COMPLAINT OF DELAYED NEEDLE RETRACTION WAS CONFIRMED FROM THE PHYSICAL SAMPLES THAT WERE PROVIDED FOR INVESTIGATION. TWENTY-EIGHT REPRESENTATIVE 22G INSYTE AUTOGUARD DEVICE FROM LOT 4290664 WERE PROVIDED FOR INVESTIGATION. A FUNCTIONAL TEST SHOWED THAT THE RETRACTION TIME OF SOME SAMPLES EXCEEDED THE SPECIFICATION LIMIT. A TREND WAS IDENTIFIED FOR COMPLAINTS OF DELAYED NEEDLE RETRACTION AND A CAPA WAS OPENED TO ADDRESS THIS ISSUE. THE APPROPRIATE MANUFACTURING PERSONNEL WERE NOTIFIED OF THIS COMPLAINT. ALL NEEDLES FULLY RETRACTED; THEREFORE, THE COMPLAINT OF NEEDLE RETRACTION FAILURE WAS NOT CONFIRMED. 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 NEEDLE RETRACTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MONDAY THIS WEEK AND NOW TODAY I HAVE RECEIVED REPORTS THAT THE BD INSYTE AUTOGUARD 20G NEEDLES ARE NOT RETRACTING WHEN THE BUTTON IS PUSHED. OR THEY DO RETRACT AFTER A DELAY OR THEY VERY SLOWLY ARE RETRACTING. EVENT DATE IS 1/13 AND 1/15.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50617 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4290664 00382903814336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown