BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADD-ON BURETTE SET

    MDR report key: 2243711 · Received July 28, 2011

    Report

    Report Number
    9616066-2011-00440
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 6, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K780130
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE INVOLVED IN THIS EVENT WILL NOT BE RETURNED AS IT WAS NOT AVAILABLE. NO FAILURE INVESTIGATION COULD BE PERFORMED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT WHEN THEY ATTEMPTED TO FLUSH THE SMARTSITE ON TOP OF THE BURETTE WITH NORMAL SALINE, THEY NOTICED A LEAK AT THE BASE OF THE NEEDLE-FREE VALVE. FROM THE REPORTED INFO, THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PT OR USER AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADD-ON BURETTE SET FPA CAREFUSION CORP. 82113E 11026200

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK