BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE EXTENSION SET

    MDR report key: 2140785 · Received June 15, 2011

    Report

    Report Number
    9616066-2011-00325
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 30, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S REPORT OF A CRACKED FEMALE LUER WAS CONFIRMED. DURING VISUAL INSPECTION, IT WAS NOTED IMMEDIATELY THAT THE FEMALE LUER HAD A 0.471 INCH CRACK IN IT. THE ROOT CAUSE OF THE CRACK WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    RECEIVED REPORT THAT AN EXTENSION SET HAD A CRACK IN THE FEMALE LUER. ALTHOUGH REQUESTED, NO ADDITIONAL CLINICAL OR PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSITE EXTENSION SET FPA CAREFUSION CORPORATION 20337E 09075814

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK