BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE NEEDLE-FREE VALVE

    MDR report key: 2060647 · Received April 8, 2011

    Report

    Report Number
    9616066-2011-00113
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Report Date
    October 29, 2010
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K061285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: 04/08/2011. (B)(4). THE CUSTOMER'S REPORT OF THE SMARTSITE VALVE SNAPPED APART WAS CONFIRMED. THE WHITE CAP (FEMALE LUER ADAPTER) WAS SEPARATED FROM THE CLEAR BODY OF THE VALVE. THE BREAK OCCURRED BELOW THE WELDING ENGAGEMENT WHERE THE BODY AND WHITE CAP CONNECT. THE ROOT CAUSE OF THE DAMAGE TO THE SMARTSITE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE CLEAR HOUSING OF THE SMARTSITE VALVE BROKE INTO TWO PIECES AT THE WHITE CAP PORTION; BREAKAGE APPEARS TO BE FAIRLY CLEAN. CUSTOMER STATED THAT IT APPEARS THE END OF THE CLEAR COMPONENT WAS SNAPPED OFF AND IS STILL BONDED INSIDE THE OPENING OF THE WHITE COMPONENT BECAUSE THE END OF THE CLEAR COMPONENT IS SLIGHTLY JAGGED WITH A SPUR THAT MATCHES UP WITH THE REMAINS INSIDE THE WHITE COMPONENT. HE SUSPECTS THAT THE DAMAGE WAS DUE TO FLEXING THE 2000E AND BREAKING IT IN HALF. HE STATED THAT THE WHITE AND CLEAR COMPONENTS DO NOT SHOW THE CHARACTERISTICS OF A WELD FAILURE. THE PRODUCT WAS ON A PT AT THE TIME. NO PT HARM OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSITE NEEDLE-FREE VALVE FPA CAREFUSION CORP. 2000E 10076177

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT: SERIAL # UNK| ALARIS PUMP MODULE: SERIAL # UNK