BEUDAMED
    FDA Adverse Event Other Summary report: N

    2 FR NEOMAGIC SAFETY OTN

    MDR report key: 1727206 · Received April 27, 2010

    Report

    Report Number
    2925153-2009-00011
    Event Type
    Other
    Date Received
    April 27, 2010
    Date of Event
    November 22, 2009
    Report Date
    April 9, 2010
    Manufacturer
    NEOMEDICAL
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS PREVIOUSLY ASSESSED AND THE DECISION WAS THERE WAS NO INDICATION FOR MDR REPORTING, BASED ON THE EXISTING MDR REPORTING CRITERIA. THIS COMPLAINT FILE WAS REVIEWED BY THREE FDA INSPECTORS AND THE CONTENTS DID NOT WARRANT A MDR REPORT FILING. NEOMEDICAL HAS UPDATED ITS COMPLAINT HANDLING AND MDR REPORTING PROCEDURES. THE 2009 AND 2010 COMPLAINT FILES WERE RE-EXAMINED AND BASED ON THE CHANGED CRITERIA, THIS MDR REPORT IS BEING FILED. AN EXAMINATION OF THE DEVICE WAS CARRIED OUT AS PART OF THE COMPLAINT INVESTIGATION. THE CONCLUSION WAS THAT THE CORRECT PROCEDURE FOR SEPARATING THE SPLITTABLE SHEATH WAS NOT FOLLOWED BY THE USER.

    Description of Event or Problem · 1

    BASED ON THE REPORT INFORMATION, SUBMITTED TO NEOMEDICAL ON (B)(6) 2009, THE ORANGE TAB OF THE INTRODUCER BROKE OFF ON ONE SIDE, LEAVING ONE TAB AND THE SHEATH STILL ON THE LINE. THE LINE WAS EXCHANGED. THE PATIENT WAS STABLE AFTER THE EVENT. THE USED PRODUCT / SAMPLE WAS AVAILABLE FOR RETURN TO NEOMEDICAL. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2 FR NEOMAGIC SAFETY OTN VASCULAR ACCESS DEVICE LJS NEOMEDICAL 2076-300 1001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention