BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 20778613 · Received November 26, 2024

    Report

    Report Number
    1710034-2024-01390
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    November 7, 2024
    Report Date
    January 6, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814343
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    INVESTIGATION RESULTS: THE COMPLAINT OF NEEDLE RETRACTION FAILURE COULD NOT BE CONFIRMED FROM THE REPRESENTATIVE 20 G INSYTE AUTOGUARD UNITS THAT WERE RECEIVED FROM LOTS 4234657, 4241244, AND 4239972. A FUNCTIONAL TEST SHOWED THAT EACH NEEDLE FULLY RETRACTED WHEN THE SAFETY MECHANISM WAS ACTIVATED. ALTHOUGH THE REPRESENTATIVE SAMPLES AND MANUFACTURING RECORDS DO NOT SUPPORT THE COMPLAINANT¿S DESCRIPTION OF THE REPORTED EVENT, THE COMPLAINT HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED AS PART OF ONGOING EFFORTS TO IDENTIFY POTENTIAL MANUFACTURING RELATED ISSUES. 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 DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER RECEIVED SI REPORTS ON NEEDLES NOT RETRACTING PROPERLY CAUSING A CHANCE FOR NEEDLE STICKS. I HAVE PULLED NEEDLES OFF THE SHELF.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2442535 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4239972 00382903814343

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown