BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM MANIFOLD KIT

    MDR report key: 6092400 · Received November 10, 2016

    Report

    Report Number
    6092400
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Date of Event
    August 2, 2016
    Report Date
    September 26, 2016
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    KDD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SETTING UP FOR HEART CATHETERIZATION WHEN IT WAS NOTICED THAT THREE WAY HOOK UP WAS CRACKED ON ONE END. KIT WAS DISCARDED AND A NEW KIT WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745218 CUSTOM MANIFOLD KIT KIT, SURGICAL INSTRUMENT, DISPOSABLE KDD MERIT MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1