BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROCLAVE MC100

    MDR report key: 5586823 · Received April 14, 2016

    Report

    Report Number
    MW5061766
    Event Type
    Injury
    Date Received
    April 14, 2016
    Date of Event
    April 12, 2016
    Report Date
    April 14, 2016
    Manufacturer
    ICU MEDICAL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RN IDENTIFIED FOREIGN SUBSTANCE IN THE SEALED CLAVE PACKAGE-PRODUCT CODE MC100 MFG BY ICU MEDICAL INC., LOT #3199934.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233442 MICROCLAVE MC100 MICROCLAVE MC100 FPA ICU MEDICAL MICROCLAVE 3199934

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention