BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILYST MEDICAL

    MDR report key: 2845046 · Received October 25, 2012

    Report

    Report Number
    1317056-2012-00042
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A USED SAMPLE FROM THE REPORTED EVENT HAS BEEN RETURNED TO NAVILYST MEDICAL, HOWEVER THE DEVICE EVALUATION IS STILL IN PROCESS. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. ((B)(4)).

    Description of Event or Problem · 1

    AS REPORTED BY THE END USER HOSPITAL, DURING PREP FOR A LEFT HEART CATHETERIZATION PROCEDURE, AIR BUBBLES WERE OBSERVED WITHIN THE COMPONENTS OF A NAVILYST MEDICAL CONVENIENCE KIT. A NEW KIT WAS PULLED FOR USE, AND THE PROCEDURE WAS ACCOMPLISHED SUCCESSFULLY. THERE WAS NO PATIENT INJURY. USED PRODUCT WAS RETURNED TO NAVILYST MEDICAL FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVILYST MEDICAL CONVENIENCE KIT LJS NAVILYST MEDICAL NA 4414116

    Patients

    Seq Age Sex Outcome Treatment
    1