BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SINGLE PORT

    MDR report key: 20984140 · Received December 19, 2024

    Report

    Report Number
    1710034-2024-01521
    Event Type
    Malfunction
    Date Received
    December 19, 2024
    Date of Event
    December 5, 2024
    Report Date
    January 31, 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 FROM THE SEPTUM WAS CONFIRMED AND THE CAUSE APPEARED TO BE MANUFACTURING RELATED. FOUR 18G NEXIVA UNITS FROM LOT 4232063 WERE PROVIDED FOR INVESTIGATION. THE CANNISTER AND SEPTUM WERE NOT SEATED CORRECTLY 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. A FUNCTIONAL TEST SHOWED THAT NO FLUID WOULD BYPASS THE CLOSED CLAMP; THEREFORE, THE COMPLAINT OF BACKFLOW COULD NOT BE CONFIRMED. 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 AT THE SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GOOD MORNING. A NURSE MANAGER EMAILED ME SAYING THEY'VE HAD 2 SEPARATE INCIDENTS WITH THIS DEVICE LEAKING (FAILED VALVE). THE LOT # REPORTED IS 423203 BUT I BELIEVE IT'S LIKELY TO BE 4232063 LIKE OTHERS I'VE REPORTED. NO IDEA IF A SERF WAS FILED FOR EITHER OF THESE DEVICES. HE HAS 1 ITEM ON HAND, AND 1 PACKAGING ON HAND. THANK YOU! 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
    2202441 BD NEXIVA SINGLE PORT PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4232063

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown