BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6" TRIFURCARTED EXTENSION SET WITH BIONECTORS

    MDR report key: 4320099 · Received December 3, 2014

    Report

    Report Number
    2245270-2014-00097
    Event Type
    Malfunction
    Date Received
    December 3, 2014
    Date of Event
    October 19, 2014
    Report Date
    December 2, 2014
    Manufacturer
    VYGON CORP.
    Product Code
    FPA
    PMA / PMN Number
    K021395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO VYGON FOR EVALUATION AND 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

    THE SET WAS FOUND LEAKING ON THE FILTER CONTAINING LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779551 6" TRIFURCARTED EXTENSION SET WITH BIONECTORS FPA VYGON CORP. BN-944 1310051

    Patients

    Seq Age Sex Outcome Treatment
    1