BEUDAMED
    FDA Adverse Event Other Summary report: N

    V-CATH MIDLINE

    MDR report key: 1671502 · Received April 27, 2010

    Report

    Report Number
    2925153-2009-00010
    Event Type
    Other
    Date Received
    April 27, 2010
    Date of Event
    October 23, 2009
    Report Date
    April 9, 2010
    Manufacturer
    NEOMEDICAL
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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 THEN EXISTING MDR REPORTING CRITERIA. THIS COMPLAINT FILE WAS REVIEWED BY THREE FDA INSPECTORS AND THE CONTENTS DID NOT WARRANT A MDR REPORT FILING. HOWEVER, 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 NEEDED TO CLARIFY THE ISSUE REPORTED, HOWEVER, THE NO PRODUCT SAMPLE HAS BEEN RETURNED TO NEOMEDICAL. BASED ON THE INFORMATION PROVIDED TO NEOMEDICAL THERE WAS NO ADVERSE EVENT.

    Description of Event or Problem · 1

    BASED ON THE REPORT INFORMATION, SUBMITTED TO NEOMEDICAL ON (B)(6) 2009, THE KITS HAVE IN THE WRONG DILATORS. THERE WAS NO PATIENTS INVOLVED AND NONE OF THE USED PRODUCTS WERE AVAILABLE FOR RETURN TO NEOMEDICAL. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-CATH MIDLINE VASCULAR ACCESS DEVICE LJS NEOMEDICAL 4049-1620 1018

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention