BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SINGLE PORT

    MDR report key: 20982898 · Received December 19, 2024

    Report

    Report Number
    1710034-2024-01517
    Event Type
    Malfunction
    Date Received
    December 19, 2024
    Date of Event
    November 29, 2024
    Report Date
    January 29, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    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. 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. 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 AT THE SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE VALVE FAILED ON THIS IV SYSTEM - BLOOD LEAKED OUT THE BACK OF THE IV SYSTEM AFTER THE NEEDLE WAS REMOVED. REGARDING PATIENT HARM/INJURY/NEGATIVE OUTCOMES, THE OUTCOME FOR THESE WAS THAT THE PATIENT NEEDED TO BE POKED AGAIN TO ESTABLISH IV ACCESS. THE IVS REMOVED WERE OTHERWISE WORKING AND SUCCESSFUL. FOR THE 18G IVS THAT LEAKED AFTER ACCESSING, THE CLINICIAN HAD TO CLEAN BLOOD OFF THE PATIENT THAT LEAKED CAUSING A LESS THAN SATISFACTORY PATIENT EXPERIENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2512945 BD NEXIVA SINGLE PORT PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4232063

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown