BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIONECTOR

    MDR report key: 4134198 · Received September 26, 2014

    Report

    Report Number
    2245270-2014-00075
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    VYGON SA
    Product Code
    FOZ
    PMA / PMN Number
    K070705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE MALFUNCTIONING DEVICE WAS NOT RETURNED TO VYGON US, THE COMPLAINT INFORMATION WAS FORWARDED TO VYGON SA FOR INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING, AND WILL BE COMMUNICATED TO FDA VIA A FOLLOW-UP MDR WITHIN THIRTY DAYS OF ITS CONCLUSION.

    Description of Event or Problem · 1

    A HIGH PRESSURE INJECTION WAS ADMINISTERED IN INTERVENTIONAL RADIOLOGY. UPON REMOVAL OF THE SYRINGE, MEMBRANE DID NOT RETURN TO PROPER ALIGNMENT. THE PORT WAS OPEN, AND THERE WAS BLEED BACK. THERE WAS NO ADVERSE OUTCOME AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602794 BIONECTOR NEEDLELESS DEVICE FOZ VYGON SA 896.038

    Patients

    Seq Age Sex Outcome Treatment
    1