BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAMIC CONVENIENCE KIT

    MDR report key: 2771701 · Received August 29, 2012

    Report

    Report Number
    2771701
    Event Type
    Malfunction
    Date Received
    August 29, 2012
    Date of Event
    April 13, 2012
    Report Date
    August 29, 2012
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    DTL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    NAVILYST MEDICAL NAMIC CONVENIENCE KIT - MANIFOLD WAS DEFECTIVE AND FOUND CRACK IN MANIFOLD WHILE PREPPING IT ON TABLE. DEVICE NOT RECEIVED BY CLINICAL ENGINEERING. IF RECEIVED, WILL RETURN TO MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAMIC CONVENIENCE KIT MANIFOLD DTL NAVILYST MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR