BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 20052867 · Received August 23, 2024

    Report

    Report Number
    1710034-2024-00918
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    August 1, 2024
    Report Date
    October 11, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825349
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE COMPLAINT THAT THE NEEDLE WOULD NOT RETRACT COULD NOT BE CONFIRMED FROM THE 20GA INSYTE AUTOGUARD UNIT FROM LOT: 4152057. THE NEEDLE WAS RECEIVED FULLY RETRACTED WITHIN THE SAFETY SHIELD AND WITH NO IV CATHETER WAS PROVIDED. A FUNCTIONAL TEST REVEALED THAT THE NEEDLE COULD RETRACT WITHOUT RESISTANCE. NO DAMAGE OR DEFECTS WERE IDENTIFIED THAT WOULD CONTRIBUTE TO THE REPORTED ISSUE. 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. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC NEEDLE SLOW TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TOOK THREE TIMES OF HITTING THE SAFETY BUTTON TO GET THE NEEDLE TO RETRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1697979 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4152057 00382903825349

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown