BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SINGLE PORT

    MDR report key: 21112167 · Received January 9, 2025

    Report

    Report Number
    1710034-2024-01592
    Event Type
    Malfunction
    Date Received
    January 9, 2025
    Date of Event
    December 18, 2024
    Report Date
    January 31, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835195
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE COMPLAINT OF A LEAK WAS CONFIRMED, AND THE CAUSE APPEARED TO BE MANUFACTURING RELATED. ONE 18G NEXIVA UNIT FROM LOT 4232063 WAS PROVIDED FOR INVESTIGATION. THE CANNISTER AND SEPTUM WERE NOTED TO BE DEFORMED WITHIN THE CATHETER ADAPTER, WHICH LIKELY CREATED A FLUID PATH THAT ALLOWED FLUID TO LEAK. CORRECTIVE ACTIONS HAVE BEEN INITIATED, AND A MANUFACTURING ROOT CAUSE HAS BEEN IDENTIFIED FOR THIS FAILURE MODE. ACTIONS HAVE BEEN MADE TO ADDRESS THE ISSUE. THE APPROPRIATE MANUFACTURING PERSONNEL WERE NOTIFIED OF THIS COMPLAINT. 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 NEXIVA 18 GA X 1-1/4 IN SINGLE PORT LEAKED AT THE SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STAFF RELAY AT THE TIME OF INSERTION, AFTER RETRACTING THE NEEDLE, BLOOD IS LEAKING FROM THE CATHETER HUB. STAFF RELAY "IT SEEMS LIKE THE VALVE IS NOT WORKING PROPERLY'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1376923 BD NEXIVA SINGLE PORT PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4235516 00382903835195

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown