BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADD-ON BURETTE SET

    MDR report key: 1972632 · Received January 19, 2011

    Report

    Report Number
    9616066-2011-00012
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 10, 2011
    Manufacturer
    CAREFUSION CORPORATION
    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

    MFR'S REPORT DATE: 01/19/2011. (B)(4). SAMPLE INVOLVED IN THIS EVENT WILL NOT BE RETURNED AS THE CUSTOMER HAS INDICATED THAT THEY HAVE DISCARDED IT. NO FAILURE INVESTIGATION COULD BE PERFORMED.

    Description of Event or Problem · 1

    THE USER REPORTED A LEAK FROM THE BASE OF THE BURETTE DURING A BLOOD TRANSFUSION. FROM THE REPORTED INFO, THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PT OR USER AS A RESULT OF THIS INCIDENT. NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADD-ON BURETTE SET FPA CAREFUSION CORPORATION 82105E 10086866

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK