BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SINGLE PORT

    MDR report key: 21936475 · Received April 30, 2025

    Report

    Report Number
    1710034-2025-00710
    Event Type
    Malfunction
    Date Received
    April 30, 2025
    Date of Event
    March 31, 2025
    Report Date
    June 9, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE COMPLAINT OF A LEAK WAS CONFIRMED DUE TO THE CIRCUMSTANTIAL EVIDENCE THAT WAS OBSERVED ON THE RETURNED SAMPLE AND THE CAUSE APPEARED TO BE MANUFACTURING RELATED. ONE 18G NEXIVA UNIT FROM LOT 4232063 WAS PROVIDED FOR INVESTIGATION. THE SEPTUM WAS MISALIGNED WITHIN THE CATHETER ADAPTER, WHICH COULD ALLOW FLUID TO LEAK DURING USE. 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 SINGLE PORT LEAKED FROM THE SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER THE IV WAS INSERTED, BLOOD WAS LEAKING OUT OF THE GRAY SEPTUM THAT THE NEEDLE SAFETIES FROM, AND WHEN FLUSHING THE LINE, SALINE WOULD SHOOT OUT OF THE SEPTUM AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182281 BD NEXIVA SINGLE PORT PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown