BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPTY EVACUATED 250 ML CONTAINER

    MDR report key: 751163 · Received August 1, 2006

    Report

    Report Number
    MW1039926
    Event Type
    Malfunction
    Date Received
    August 1, 2006
    Date of Event
    July 1, 2006
    Report Date
    August 1, 2006
    Manufacturer
    *
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    TWO INDIVIDUAL PLASS IV BOTTLES HAVE BEEN IDENTIFIED IN OUR IV ROOM WITH RUST COLORED DEFECTS IN OR ON THE INSIDE OF THE GLASS. EACH IS AN EMPTY EVACUATED CONTAINER.THE ORIGIN/COMPOSITION IS UNK EXCEPT THAT THEY APPEAR TO HAVE BEEN PRESENT AT MANUFACTURING. PRODUCT ONE: LIST NO. 1614-02, LOT: 34-720-DN-01. EXP: OCT 2007, PRODUCT TWO: LIST NO. 1614-03, LOT: 37-034-DM-01, EXP: 1 JAN, 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMPTY EVACUATED 250 ML CONTAINER * KPE * * 34-720-DM-01
    2 EMPTY EVACUATED CONTAINER 500 ML * KPE * * 34-034-DM-01

    Patients

    Seq Age Sex Outcome Treatment
    1 *