BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT

    MDR report key: 17467412 · Received August 6, 2023

    Report

    Report Number
    1710034-2023-00875
    Event Type
    Malfunction
    Date Received
    August 6, 2023
    Date of Event
    July 19, 2023
    Report Date
    September 6, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835362
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH TWO PHOTOS OF THE ISSUE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 3011703, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTOS AND OBSERVED THAT THE LUER PORTS OF THE Y-ADAPTER WERE DEFORMED. THERE APPEARED TO BE A SPLIT THAT EXTENDED PAST THE LUER THREADS. THEREFORE, BASED OFF THE PROVIDED PHOTOS THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. IT WAS DETERMINED THAT THIS WAS A MANUFACTURING RELATED ISSUE THAT OCCURRED DURING THE ASSEMBLY PROCESS.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ONE OF THE PORTS ON THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT BROKE AND WAS FOUND AFTER THE INSERTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "NEXIVA WITH ONE OF THE BROKEN PORTS, IDENTIFICATION OF THE PROBLEM AFTER INSERTION."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ONE OF THE PORTS ON THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT BROKE AND WAS FOUND AFTER THE INSERTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "NEXIVA WITH ONE OF THE BROKEN PORTS, IDENTIFICATION OF THE PROBLEM AFTER INSERTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1106583 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3011703 00382903835362

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown