BEUDAMED
    FDA Adverse Event Death Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 7531192 · Received May 21, 2018

    Report

    Report Number
    9610847-2018-00148
    Event Type
    Death
    Date Received
    May 21, 2018
    Date of Event
    May 7, 2018
    Report Date
    May 23, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    00382903835515
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    NO SAMPLE OR PHOTO WAS RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF REPORTED LOT NUMBER 7143594. WITHOUT DEFECTIVE SAMPLE OR PHOTO FOR US IS VERY DIFFICULT TO DETERMINE THE ROOT OF CAUSE OF THE INCIDENT. WE WERE NOT ABLE TO ASSOCIATE THE REPORTED DEFECT TO THE MFG. PROCESS. NO CAPA WAS OPENED SINCE THIS ISSUE COULD NOT BE CONFIRMED AS MANUFACTURING RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NURSE PLACED THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INSTEAD OF A SQ BUTTERFLY. DESPITE THEM BEING WELL LABELLED. THE PATIENT WAS PALLIATIVE AND DIED DUE TO DISEASE PROGRESSION. NURSE STATED THEY LOOKED THE SAME AND SHE THOUGHT THE NEXIVA WAS THE SQ BUTTERFLY. FOUND DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371778 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR ADMINISTRATION SET FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7143594 00382903835515

    Patients

    Seq Age Sex Outcome Treatment
    1 Death