BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAMP ALERT VIAL

    MDR report key: 39613 · Received September 24, 1996

    Report

    Report Number
    MW1009975
    Event Type
    Malfunction
    Date Received
    September 24, 1996
    Date of Event
    September 11, 1996
    Report Date
    September 15, 1996
    Manufacturer
    EPS, INC.
    Product Code
    KYW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    DARK SPECK FOUND IN VIAL. HAVE ALSO SEEN IN OTHER LOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAMP ALERT VIAL EMPTY VIAL FOR MEDICATION KYW EPS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *