BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 17716761 · Received September 9, 2023

    Report

    Report Number
    1710034-2023-01030
    Event Type
    Malfunction
    Date Received
    September 9, 2023
    Date of Event
    August 24, 2023
    Report Date
    July 26, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903925339
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO SAMPLE OR PHOTO AVAILABLE TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. WE REGRET ANY INCONVENIENCES THIS INCIDENT MAY HAVE CAUSED YOU AND YOUR FACILITY. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WAS FRAYED AT THE TIP. REPORT 1 OF 2. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: WE STARTED USING THE NEW IV CATHETERS FROM BD THIS WEEK. BESIDES THAT THESE IV CATHETERS ARE NOT AS SMOOTH TO INSERT & ARE TAKING THE AMBULATORY NURSES MULTIPLE ATTEMPTS TO GET AN IV STARTED SUCCESSFULLY SINCE SWITCHING TO THESE NEW CATHETERS, THIS PARTICULAR 20 G IV FROM BD WAS FRAYED AT THE TIP/BEVEL & A PART OF THE PLASTIC TIP DETACHED RIGHT BEFORE THE RN WENT TO INSERT THE TIP INTO THEIR PTS VEIN. THIS PARTICULAR IV CATHETER WAS NEVER INSERTED INTO A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242322 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3181567 00382903925339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown