BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFUSE NON-VENTED ADMINISTRATION SET FILTER, 1.2 MICRON

    MDR report key: 22380 · Received June 12, 1995

    Report

    Report Number
    MW1006199
    Event Type
    Malfunction
    Date Received
    June 12, 1995
    Date of Event
    May 22, 1995
    Report Date
    May 30, 1995
    Manufacturer
    BLOCK MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    TUBINGS WERE CRACKED, LEAKING TPN FLUID INTO THE PUMP. OCCURRED WITH MULTIPLE PTS OVER 1 WEEK PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFUSE NON-VENTED ADMINISTRATION SET FILTER, 1.2 MICRON NON-VENTED ADMINISTRATION SET FPA BLOCK MEDICAL, INC. V021014 42404

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other