BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SINGLE PORT

    MDR report key: 21914583 · Received April 25, 2025

    Report

    Report Number
    1710034-2025-00671
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    January 16, 2025
    Report Date
    April 15, 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
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 383519 AND LOT NUMBER 4232063. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. BASED ON THE AVAILABLE INFORMATION, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    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: EVENT DISCRIPTION IV CATHETER BEGAN TO HAVE BLOOD FLOW FROM THE GREY NEEDLE INLET PART OF THE IV CATHETER. THIS HAS OCCURRED BEFORE WITH OTHER IV CATHETERS - POTENTIAL IT IS ONLY 18G BUT WILL SUBMIT OTHER ERS IF OTHERS DO THIS. EVENT DATE (B)(6) 2025 PATIENT HARM NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825581 BD NEXIVA SINGLE PORT PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4232063 00382903835195

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown