BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP TUBING

    MDR report key: 9595876 · Received January 15, 2020

    Report

    Report Number
    MW5092263
    Event Type
    Malfunction
    Date Received
    January 15, 2020
    Date of Event
    October 1, 2019
    Report Date
    January 14, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BACK CHECK VALVE FAILURE. RITUXAN SECONDARY BACK-FLOWED INTO THE PRIMARY FLUID BAG AFTER BEING INSERTED INTO THE PUMP AND BEFORE ATTACHED TO THE PATIENT. FDA SAFETY REPORT ID # (B)(4). FDA RECEIVED DATE 01/14/2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57065 ALARIS PUMP TUBING SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON, DICKINSON AND COMPANY 1912611D

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR