BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    14" EXTENSION SET

    MDR report key: 2093054 · Received April 15, 2011

    Report

    Report Number
    2245270-2011-00017
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    February 17, 2011
    Report Date
    April 15, 2011
    Manufacturer
    VYGON
    Product Code
    FPA
    PMA / PMN Number
    K021395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS SENT BACK TO VYGON FOR EVALUATION, HOWEVER THE LOT NUMBER WAS NOT AVAILABLE. THE DEVICE EVALUATION IS PENDING. A FOLLOW UP MDR WILL BE SUBMITTED ONCE THE COMPLAINT INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    TUBING CAME APART AT DISTAL END OF FLOW REGULATOR AFTER ADMINISTERING MEDICATION. NO HARM WAS DONE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 14" EXTENSION SET EXTENSION SET FPA VYGON 43000E

    Patients

    Seq Age Sex Outcome Treatment
    1