BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL

    MDR report key: 4945829 · Received July 22, 2015

    Report

    Report Number
    MW5044804
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Report Date
    July 22, 2015
    Manufacturer
    APP PHARMACEUTICALS
    Product Code
    KYX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    CALCIUM GLUCONATE 10% - 10ML VIAL; MFR APP PHARMACEUTICALS; HAS WHITE PARTICULATE MATTER IN VIALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474339 VIAL VIAL KYX APP PHARMACEUTICALS 6008883

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR