BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LECTROSPIRAL

    MDR report key: 3908706 · Received May 1, 2014

    Report

    Report Number
    2245270-2014-00042
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    March 14, 2014
    Report Date
    April 30, 2014
    Manufacturer
    VYGON SA
    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 TWO ADD'L OCCURRENCE OF THIS DEVICE MALFUNCTION. PLEASE REFERENCE THE BELOW MDR NUMBERS FOR REPORTING OF THIS ADD'L OCCURRENCE. MDR 2245270-2014-00041, 00043. VYGON US RECEIVED ONE MALFUNCTIONING SAMPLE FROM THE CUSTOMER AND RETURNED IT TO VYGON (B)(4) (THE MANUFACTURER FOR DEVICE EVAL AND COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING, AND THE RESULTS WILL BE SENT TO FDA VIA A F/U MDR WITHIN THIRTY DAYS OF ITS CONCLUSION.

    Description of Event or Problem · 1

    LECTRO-SPIRAL CRACKING/LEAKING NEAR NECK/ADAPTOR END TO IV TUBING. PT LOST PARENTERAL NUTRITION, REQUIRED NEW LINES, AND ALTERED BIOCHEMISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263603 LECTROSPIRAL INTRAVASCULAR EXTENSION SET FPA VYGON SA 1159.70 120713AP

    Patients

    Seq Age Sex Outcome Treatment
    1 29 MO