BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD YEL 24GA X .75IN

    MDR report key: 21329325 · Received February 6, 2025

    Report

    Report Number
    1710034-2025-00151
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Date of Event
    January 17, 2025
    Report Date
    February 28, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814121
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE COMPLAINT OF NEEDLE RETRACTION FAILURE COULD NOT BE CONFIRMED FROM THE VIDEO THAT WAS PROVIDED FOR INVESTIGATION. THE VIDEO SHOWED THE NEEDLE FULLY RETRACTING; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. THE NEEDLE RETRACTED SLOWLY, WHICH WAS ADDRESSED IN INVESTIGATION #(B)(4). ALTHOUGH THE COMPLAINT COULD NOT BE CONFIRMED, A TREND WAS IDENTIFIED FOR NEEDLE RETRACTION FAILURE COMPLAINTS AND A CAPA WAS OPENED TO ADDRESS THIS ISSUE. THIS COMPLAINT TYPE AND CORRECTIVE ACTION WILL CONTINUE TO BE MONITORED FOR EFFECTIVENESS. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    MATERIAL: 381412 BATCH#: 4123600. IT WAS REPORTED THAT THE BD INSYTE AUTOGUARD YEL 24GA X .75IN HAD A NEEDLE RETRACTION FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE IS RETRACTING SLOW OR NOT RETRACTING AT ALL ON INSYTE AUTOGUARD. ADDITIONAL INFORMATION PROVIDED: 1. CAN YOU SHARE ANY PHYSICAL SAMPLE OR PHOTO IF AVAILABLE FOR INVESTIGATION? IF YES, PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? SEE VIDEO OF DELAYED RETRACTION. RANDY (OUR REP) WAS IN THE ROOM AND WITNESSED THE PRODUCT ISSUE. 2. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. 2REPORTS OF SAFETY RISK REGARDING NEEDLE STICKS IF NEEDLE DIDN¿T RETRACT FOR INSERTER, AND MULTIPLE ATTEMPTS BY INSERTERS DUE TO BELIEVED FAILURE OF DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1310949 BD INSYTE AUTOGUARD YEL 24GA X .75IN PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4123600 00382903814121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown