BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE EXTENSION SET

    MDR report key: 3717770 · Received February 26, 2014

    Report

    Report Number
    9616066-2014-00159
    Event Type
    Malfunction
    Date Received
    February 26, 2014
    Date of Event
    January 29, 2014
    Report Date
    February 6, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K061285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CONNECTOR HAS BEEN RECEIVED AND THE VALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    RN REPORTED TO PURCHASING MANAGER: "NOT SURE IF SOMETHING HAPPENED WHEN I CONNECTED MY CAP (MAXPLUS) TO MY T-CONNECTOR, BUT WHEN I STARTED MY IV AND WENT TO CONNECT MY T-CONNECTOR - THE BLOOD CAME SPEWING BACK OUT OF A CRACK BETWEEN THE CONNECTOR AND THE BLUE HUB." THERE WAS NO REPORT OF PATIENT HARM OR MEDICAL INTERVENTION. THE CUSTOMER STATES THAT NO FURTHER PATIENT/EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117581 SMARTSITE EXTENSION SET FPA CAREFUSION CORPORATION 20041E UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MAXPLUS VALVE: MODEL/LOT: UNK