BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM MANIFOLD KIT

    MDR report key: 3034379 · Received April 3, 2013

    Report

    Report Number
    3034379
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    February 28, 2013
    Report Date
    April 3, 2013
    Manufacturer
    MERIT MEDICAL SYSTEMS INC.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE TUBING WAS BEING PRIMED PRIOR TO USE DURING A PROCEDURE. THE PRESSURE TUBING POPPED OFF OF THE MALE ADAPTER THAT CONNECTS TO THE MANIFOLD.======================MANUFACTURER RESPONSE FOR CUSTOM MANIFOLD KIT K09-05755 REVISION F, (BRAND NOT PROVIDED) (PER SITE REPORTER),======================DEVICE WILL BE RETURNED TO THE MANUFACTURER. MANUFACTURER WILL SEND A REPORT AFTER EVALUATION IS COMPLETED AND WILL HAVE THE SALES REP FOLLOW UP WITH FACILITY. THIS IS THE 3RD REPORTED EVENT FOR THIS DEVICE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135824 CUSTOM MANIFOLD KIT ADAPTOR, STOPCOCK, MANIFOLD DXT MERIT MEDICAL SYSTEMS INC. * H397320

    Patients

    Seq Age Sex Outcome Treatment
    1 *