BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SP WITH MAXZERO

    MDR report key: 21252886 · Received January 28, 2025

    Report

    Report Number
    1710034-2025-00079
    Event Type
    Malfunction
    Date Received
    January 28, 2025
    Date of Event
    November 3, 2024
    Report Date
    January 27, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835577
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS THE RESULT OF AN INVESTIGATION FINDING. THE COMPLAINT OF COMPLICATIONS WHEN PULLING THE WHITE NEEDLE GRIP FROM THE GREY TIP SHIELD COMPONENT WAS CONFIRMED AND THE CAUSE APPEARED TO BE MANUFACTURING RELATED. FOUR 20G NEXIVA UNITS FROM LOT #4193548 WERE PROVIDED FOR INVESTIGATION. A FUNCTIONAL TEST SHOWED THAT EACH NEEDLE WAS DIFFICULT TO DISENGAGE. RESISTANCE WAS IDENTIFIED BETWEEN THE NEEDLE AND THE TIP SHIELD COMPONENT. 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. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. WE REGRET ANY INCONVENIENCES THIS INCIDENT MAY HAVE CAUSED YOU AND YOUR FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA 20 GA X 1.25IN SP WITH MAXZERO UNABLE TO PULL THE NEEDLE APART. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 383557. BATCH # 4193548. IT WAS REPORTED BY CUSTOMER THAT UNABLE TO PULL WHITE AND GREY APART TO BREAK THE SEAL. VERBATIM: UNABLE TO PULL WHITE AND GREY APART TO BREAK THE SEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2377832 BD NEXIVA SP WITH MAXZERO PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4193548 00382903835577

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown