BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK

    MDR report key: 4143567 · Received August 8, 2014

    Report

    Report Number
    4143567
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 8, 2014
    Manufacturer
    BECTON DICKINSON & CO.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DARK SPOTS/STAINS INSIDE STERILE PACKAGE ON THE DEVICE ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468862 INTERLINK SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON & CO. 303370 4119751

    Patients

    Seq Age Sex Outcome Treatment
    1 *