BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE

    MDR report key: 321370 · Received March 16, 2001

    Report

    Report Number
    MW1021353
    Event Type
    Malfunction
    Date Received
    March 16, 2001
    Date of Event
    March 16, 2001
    Report Date
    March 16, 2001
    Manufacturer
    METRIX CO.
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    WHILE COMPOUNDING TPN AND TRANSFERING LIPIDS TO TOP OF DUAL CHAMBER BAG A DISTINCT LIGHT BROWN DISCOLORATION OF THE PLASTIC WAS NOTED AGAINST THE WHITE OF THE LIPIDS. NORMAL COLOR OF PLASTIC IS CLEAR. NEW BAGS USED, BAGS IN QUESTION NOT DISPENSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11967 SECURE DUAL CHAMBER TPN BAG KPE METRIX CO. DUAL CHAMBER CONTAINER 10408

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other