BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM MANIFOLD KIT

    MDR report key: 2749375 · Received September 14, 2012

    Report

    Report Number
    2749375
    Event Type
    Malfunction
    Date Received
    September 14, 2012
    Date of Event
    September 13, 2012
    Report Date
    September 14, 2012
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DTL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TUBING WAS BEING PRIMED PRIOR TO USE DURING A PROCEDURE. WHILE FLUSHING THE MALE ADAPTER THAT CONNECTED THE TUBING TO THE MANIFOLD CAME OFF. THE ADAPTER AND THE TUBING WERE NOT BONDED (OR FUSED)TOGETHER. THIS IS THE SECOND REPORT RELATED TO THIS PARTICULAR MANIFOLD KIT THAT WE HAVE SUBMITTED.======================MANUFACTURER RESPONSE FOR CUSTOM MANIFOLD KIT K09-05755 REVISION F, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================THEY WILL SEND PACKAGING TO RETURN THE DEVICE TO THEM FOR AN EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM MANIFOLD KIT ADAPTOR, STOPCOCK, MANIFOLD DTL MERIT MEDICAL SYSTEMS, INC. * H373669

    Patients

    Seq Age Sex Outcome Treatment
    1 *