BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SINGLE PORT

    MDR report key: 21914772 · Received April 25, 2025

    Report

    Report Number
    1710034-2025-00676
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    April 8, 2025
    Report Date
    May 23, 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
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE COMPLAINT OF A LEAK WAS CONFIRMED, AND THE CAUSE APPEARED TO BE MANUFACTURING RELATED. SEALED REPRESENTATIVE UNITS FROM LOTS 4232063 AND 4235516 WERE PROVIDED FOR INVESTIGATION. A LEAK WAS CONFIRMED FROM EACH LOT DUE TO DAMAGE AT THE SEPTUM AND CANNISTER THAT WAS LIKELY CAUSED DUE TO MISALIGNMENT DURING ASSEMBLY. 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

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY ARE LEAKING AT THE BACK OF THE BUTTERFLY. INJURIES OR ADVERSE EVENT: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346354 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