BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LECTROSPIRAL

    MDR report key: 3817927 · Received April 2, 2014

    Report

    Report Number
    2245270-2014-00021
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Date of Event
    February 20, 2014
    Report Date
    April 2, 2014
    Manufacturer
    VYGON CORP.
    Product Code
    FPA
    PMA / PMN Number
    K883612
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLINICIAN REPORTED ONE ADDITIONAL OCCURRENCE OF THIS DEVICE MALFUNCTION. PLEASE REFERENCE THE BELOW MDR NUMBER FOR REPORTING OF THIS ADDITIONAL OCCURRENCE. MDR 2245270-2014-00022. VYGON US RECEIVED THE MALFUNCTIONING SAMPLE FROM THE CUSTOMER AND RETURNED IT TO VYGON SA (THE MANUFACTURER FOR DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING, AND THE RESULT SWILL BE SENT TO FDA VIA A FOLLOW-UP MDR WITHIN THIRTY DAYS OF ITS CONCLUSION.

    Description of Event or Problem · 1

    A LEAK OCCURRED AT THE HUB OF THE EXTENSION SET. THE SET WAS REPLACED. NO ILL OUTCOME WAS REPORTED BY THE CLINICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199766 LECTROSPIRAL INTRAVASCULAR EXTENSION SET FPA VYGON CORP. 1159.70 270913AP

    Patients

    Seq Age Sex Outcome Treatment
    1