BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSOTE NEEDLE-FREE VALVE

    MDR report key: 4214101 · Received August 6, 2014

    Report

    Report Number
    9616066-2014-00820
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 19, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K061285
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS FILED BY THE MANUFACTURER. THE MODEL#/CATALOG# IDENTIFIED IS A CAREFUSION PRODUCT WHICH IS SAME OR SIMILAR TO A DEVICE THAT IS APPROVED FOR SALE DOMESTICALLY. (B)(4). THE 510K NUMBER PROVIDED IS FOR THE DOMESTIC SIMILAR PRODUCT. ALTHOUGH REQUESTED, THE DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    A BBRAUN 3 WAYS STOPCOCK WITH EXTENSION SET WAS CONNECTED TO A SMARTSITE. THE CUSTOMER REPORTED THAT DURING THE INFUSION OF A CONTRAST MEDIUM IN RADIOLOGY AT A RATE OF 3ML/SEC THE SMARTSITE OCCLUDED AND CAUSED THE BBRAUN PRODUCT TO BREAK. FROM THE REPORTED INFORMATION, THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PATIENT OR USER AS A RESULT OF THIS INCIDENT. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459181 SMARTSOTE NEEDLE-FREE VALVE FPA CAREFUSION CORPORATION 2000E7D 14026169

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK BBRAUN 3 WAY STOPCOCK WITH EXTENSION SET,| (CODE 16520C - LOT 14C2045099),| THERAPY DATE: