BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA

    MDR report key: 19642874 · Received July 1, 2024

    Report

    Report Number
    19642874
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    May 22, 2024
    Report Date
    June 4, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SITUATION: IV CATHETER FAILED PRIOR TO INSERTION IN THE PEDIATRIC PATIENT. BACKGROUND: RN ([REDACTED NAME]) REPORTED IV CATH FAILURE TO ADN AND COMPLETED SAFER REPORT. ASSESSMENT/RECOMMENDATION: LOT NUMBER 4029680, REF # 383511. 25G .75 INCHES (19MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2214174 BD NEXIVA CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ BECTON, DICKINSON AND COMPANY 383511 4029680

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown