BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEROYAL

    MDR report key: 3644253 · Received February 7, 2014

    Report

    Report Number
    3005011024-2014-00001
    Event Type
    Injury
    Date Received
    February 7, 2014
    Date of Event
    January 7, 2014
    Report Date
    January 7, 2014
    Manufacturer
    ELCAM MEDICAL ACAL
    Product Code
    KDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE PRODUCT IS DIFFERENT AND DOES NOT WORK FOR THEM. DEROYAL: THE BILL OF MATERIALS FOR THE PRODUCT WAS REVIEWED AND THE ONLY CHANGE FOUND WAS TO THE PACKAGING IN APRIL 2013; THERE HAVE BEEN NO CHANGE TO THE ACTUAL DEVICE. THE END USER WAS CONTACTED FOR FURTHER INFO, AND IT WAS FOUND THAT THEY ARE USING A TECHNIQUE WHERE THE GUIDEWIRE IS PUT THROUGH THE STOPCOCK. THE GUIDEWIRE DID NOT PASS THROUGH THE STOPCOCK SMOOTHLY DUE TO THE LUMEN BEING TOO SMALL, AND THEREFORE CAUSED EXCESS BLEEDING TO THE PT. THIS TECHNIQUE IS OUTSIDE THE INDICATIONS FOR USE. THE INSTRUCTIONS THAT ARE PROVIDED WITH THE STOPCOCK STATE THAT THIS DEVICE IS TO BE USED DURING CARDIAC CATHETERIZATION PROCEDURES FOR INTRA-ARTERIAL AND INTRAVENOUS ADMINISTRATION OF CONTRAST, SALINE OR RADIOGRAPHIC CONTRAST MEDIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT IS DIFFERENT AND DOES NOT WORK FOR THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80552 DEROYAL NONE KDD ELCAM MEDICAL ACAL 32550980

    Patients

    Seq Age Sex Outcome Treatment
    1 Other