BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA

    MDR report key: 20836565 · Received December 3, 2024

    Report

    Report Number
    1710034-2024-01423
    Event Type
    Malfunction
    Date Received
    December 3, 2024
    Date of Event
    November 12, 2024
    Report Date
    January 16, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835324
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE COMPLAINT OF A LEAK WAS CONFIRMED, AND THE CAUSE OF THE LEAK APPEARED TO BE MANUFACTURING RELATED DUE TO THE LOCATION AND CHARACTERISTICS FOUND AT THE LEAK SITE. ONE PHOTOGRAPH AND ONE 22G NEXIVA IV CATHETER WERE PROVIDED FOR INVESTIGATION. THE SAMPLE EXHIBITED EVIDENCE OF USE. A SEMI-CIRCUMFERENTIAL BREACH WAS OBSERVED IN THE EXTENSION TUBING. IT APPEARED THAT THE TUBING WAS PINCHED, WHICH LIKELY OCCURRED DURING MANUFACTURING. 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 LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I CAN¿T REMEMBER IF YOU¿RE THE APPROPRIATE PERSON TO REACH OUT TO. XXX CAME TO ME TODAY REGARDING AN IV THAT WAS USED TODAY. THEY STARTED THE IV IN PREOP AND IT WAS LEAKING FROM THE J LOOP. I ENCLOSED A PHOTO OF THE PACKAGING BUT IT¿S HARD TO READ SO I¿LL TYPE IT HERE! EXP. 2027-08-31, LOT 4242260, MANUFACTURE 2024-09-01. NOT SURE WHAT THE TOP NUMBER IS BUT I¿LL INCLUDE THAT TOO: (B)(4). 15 NOV: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO ¿ BUT THE PATIENT REQUIRED AN ADDITIONAL IV START BECAUSE THE PRODUCT WAS DEFECTIVE. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 12-NOV-2024. TOTAL NUMBER OF OCCURRENCES? 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1378084 BD NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4242260 00382903835324

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown