BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 20069488 · Received August 26, 2024

    Report

    Report Number
    1710034-2024-00933
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    August 2, 2024
    Report Date
    November 14, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825127
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS THE COMPLAINT OF COMPLICATIONS DURING THE INSERTION PROCESS AND NEEDLE RETRACTION COULD NOT BE CONFIRMED FROM THE REPRESENTATIVE 24GA INSYTE AUTOGUARD UNITS THAT WERE RECEIVED IN SEALED PACKAGING FROM LOT: 4141574. NO DAMAGE OR DEFECTS WERE IDENTIFIED ON THE RETURNED SAMPLES. A FUNCTIONAL TEST TO SIMULATE NEEDLE TIP AND CATHETER TIP PENETRATION AND CATHETER DRAG SHOWED THAT THE MEASURED FORCES WERE WITHIN SPECIFICATION. THE NEEDLES RETRACTED WITHOUT ANY COMPLICATION. THE AFFECTED UNITS WERE NOT PROVIDED FOR INVESTIGATION. 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

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON 8/2/2024, HARD TO ENGAGE NEEDLE SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293432 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4141574 00382903825127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown