BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFUSE PCA RESERVOIR ADMINISTRATION SET

    MDR report key: 170989 · Received June 3, 1998

    Report

    Report Number
    MW1013913
    Event Type
    Malfunction
    Date Received
    June 3, 1998
    Date of Event
    June 2, 1998
    Report Date
    June 3, 1998
    Manufacturer
    BLOCK MEDICAL, INC.
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    AS RN ATTEMPTES TO CONNECT ADMINISTRATION SET THROUGH THE VERIFUSE PUMP, THE TUBING CAME OUT OF THE RESERVOIR. THE RESULT WAS A CONTAMINATED ADMINISTRATON SET AND WASTED MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFUSE PCA RESERVOIR ADMINISTRATION SET IV DRUG RESERVOIR & ADMINISTRATION SET MEA BLOCK MEDICAL, INC. V021012 63035

    Patients

    Seq Age Sex Outcome Treatment
    1 *