BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH DUAL PORT

    MDR report key: 8828147 · Received July 25, 2019

    Report

    Report Number
    1710034-2019-00790
    Event Type
    Malfunction
    Date Received
    July 25, 2019
    Date of Event
    July 10, 2019
    Report Date
    September 4, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835363
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THERE WERE NO SAMPLES OR PHOTOS AVAILABLE TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD NEXIVA¿ CLOSED IV CATHETER SYSTEMS WITH THE DUAL PORT WERE DIFFICULT TO DISENGAGE FROM THE NEEDLE ONCE THEIR IV WAS STARTED DURING USE, AND THE CATHETERS HAD TO BE REMOVED AND NEW IVS STARTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LAST WEEK WE HAD TWO OCCURRENCES WITH NOT BEING ABLE TO MOVE THE IV CATHETER OFF THE NEEDLE ONCE IV WAS INITIALLY STARTED. IV CATHETER HAD TO BE REMOVED AND NEW IV STARTED (REQUIRING PATIENT TO GET POKED A SECOND TIME UNECESSARILY). THE IVS WERE THE BD NEXIVA 20GA 1.00IN (1.1 X25MM) BOTH WITH LOT NUMBER 9122557."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EVALUATED BY MFR: 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 · 1

    IT WAS REPORTED THAT 2 BD NEXIVA¿ CLOSED IV CATHETER SYSTEMS WITH THE DUAL PORT WERE DIFFICULT TO DISENGAGE FROM THE NEEDLE ONCE THEIR IV WAS STARTED DURING USE, AND THE CATHETERS HAD TO BE REMOVED AND NEW IVS STARTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LAST WEEK WE HAD TWO OCCURRENCES WITH NOT BEING ABLE TO MOVE THE IV CATHETER OFF THE NEEDLE ONCE IV WAS INITIALLY STARTED. IV CATHETER HAD TO BE REMOVED AND NEW IV STARTED (REQUIRING PATIENT TO GET POKED A SECOND TIME UNNECESSARILY). THE IVS WERE THE BD NEXIVA 20GA 1.00IN (1.1 X25MM) BOTH WITH LOT NUMBER 9122557."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623217 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH DUAL PORT INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9122557 30382903835363

    Patients

    Seq Age Sex Outcome Treatment
    1 Other