BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE NEEDLE-FREE VALVE

    MDR report key: 1912951 · Received November 18, 2010

    Report

    Report Number
    9616066-2010-00332
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    May 1, 2010
    Report Date
    May 5, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K061285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE INVOLVED IN THIS EVENT WAS NOT RETURNED BY CUSTOMER. NO FAILURE INVESTIGATION COULD BE PERFORMED. THE MODEL#/CATALOG# IDENTIFIED IN SECTION D4 IS A CAREFUSION PRODUCT WHICH IS SAME OR SIMILAR TO A DEVICE THAT IS APPROVED FOR SALE DOMESTICALLY. THE DOMESTIC SIMILAR LIST NUMBER IS INDICATED: "OTHER#". THE 510K NUMBER PROVIDED IN SECTION IS FOR THE DOMESTIC SIMILAR PRODUCT.

    Description of Event or Problem · 1

    USER REPORTED THAT THEY NOTICED A SMALL AMOUNT OF FLUID LEAKING FROM THE SMARTSITE NEEDLE-FREE VALVE WHEN THEY ATTEMPTED TO FLUSH IT. NO ADD'L INFO PROVIDED. 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 SMARTSITE NEEDLE-FREE VALVE FPA CAREFUSION CORPORATION 2000E7D UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK