BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LECTROSPIRAL

    MDR report key: 8226057 · Received January 8, 2019

    Report

    Report Number
    2245270-2019-00001
    Event Type
    Malfunction
    Date Received
    January 8, 2019
    Date of Event
    July 6, 2018
    Report Date
    March 12, 2019
    Manufacturer
    VYGON
    Product Code
    FPA
    PMA / PMN Number
    K883612
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT HAS BEEN SUBMITTED TO VYGON FRANCE, WHICH IS WHERE THIS PART WAS MANUFACTURED, FOR EVALUATION. AFTER INVESTIGATING THIS CLAIM VYGON FRANCE CANNOT CONFIRM A MANUFACTURING DEFECT AS THE FAULTY SAMPLE WAS NOT RETURNED. ADDITIONALLY, THE PRODUCT'S BATCH NUMBER WAS NOT PROVIDED SO A BATCH DOCUMENTATION REVIEW COULD NOT BE COMPLETED. UNFORTUNATELY, WITHOUT ADDITIONAL INFORMATION, WE ARE UNABLE TO PERFORM ADDITIONAL INVESTIGATE FOR THE REPORTED PROBLEM. CORRECTIVE ACTION: NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. HOWEVER, BOTH VYGON FRANCE AND VYGON USA WILL ENTER THIS INCIDENT INTO OUR COMPLAINT LOG AND CONTINUE MONITORING FOR THIS PROBLEM.

    Description of Event or Problem · 0

    MOTHER REPORTED THAT THE TUBING WAS LEAKING ALTHOUGH PROPERLY ATTACHED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO VYGON FOR EVALUATION BUT THE EVENTS WILL BE PART OF COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING, AND WILL BE COMMUNICATED TO FDA WITHIN 30 DAYS OF ITS CONCLUSION.

    Description of Event or Problem · 1

    MOTHER REPORTED THAT THE TUBING WAS LEAKING ALTHOUGH PROPERLY ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19571 LECTROSPIRAL INTRASVACULAR ADMINISTRATION SET FPA VYGON 1159.70

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR