BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS

    MDR report key: 551020 · Received October 7, 2004

    Report

    Report Number
    551020
    Event Type
    Other
    Date Received
    October 7, 2004
    Date of Event
    August 26, 2004
    Report Date
    October 7, 2004
    Manufacturer
    ALARIS MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IV TUBING SPIKE CAME OUT OF CHEMOTHERAPY DRUG BOTTLE WHILE PATIENT WAS GOING TO BATHROOM.IV TUBING WAS FROM ALARIS, AND THE BOTTLE WAS FROM ABBOTT AND THE TYPE OF MEDICATION IN THE BOTTLE MAY HAVE CONTRIBUTED AND ACTED AS A LUBRICANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS IV TUBING FPA ALARIS MEDICAL SYSTEMS, INC. UNK 04076364
    2 EVACUATED CONTAINER GLASS 1000 ML EVACUATED CONTAINER KPE HOSPIRA GLOBAL MEDICAL AFFAIRS UNK 15 844 DM 01

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR CHEMOTHERAPY