BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8323729 · Received February 8, 2019

    Report

    Report Number
    9610847-2019-00135
    Event Type
    Malfunction
    Date Received
    February 8, 2019
    Date of Event
    January 16, 2019
    Report Date
    February 28, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    30382903835912
    PMA / PMN Number
    K173354
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 6153743. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ALTHOUGH PHOTOS WERE SUBMITTED FOR EVALUATION, THEY DID NOT DISPLAY THE FAILURE MODE CLEARLY ENOUGH TO IDENTIFY THE ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM THE "CATHETER WAS REMOVED FROM THE PACKAGING TO FIND CATHETER TIP EXTENDED PAST END OF NEEDLE SHAFT."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM THE "CATHETER WAS REMOVED FROM THE PACKAGING TO FIND CATHETER TIP EXTENDED PAST END OF NEEDLE SHAFT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117411 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 6153743 30382903835912

    Patients

    Seq Age Sex Outcome Treatment
    1 Other