BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE ADD ON BAG ACCESS DEVICE

    MDR report key: 6096696 · Received November 11, 2016

    Report

    Report Number
    9616066-2016-01555
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    October 20, 2016
    Report Date
    October 21, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: B.BRAUN 500ML BAG ETOPOSIDE IN 0.9% NACL, NDC 0264-7800-10, LOT J6J086, EXP 01/2019. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT THAT THE SET LEAKED WAS NOT CONFIRMED. THE SET WAS VISUALLY INSPECTED AND NO ANOMALIES WERE OBSERVED. FUNCTIONAL AND PRESSURE TESTING RESULTED IN THE SET FLOWING FREELY WITHOUT ANY LEAKING NOTED ON THE TUBING OR AT ANY OF THE COMPONENTS. THE ROOT CAUSE OF THE CUSTOMER¿S REPORT WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A LEAK AT AN UNSPECIFIED LOCATION DURING THE ADMINISTRATION OF ETOPOSIDE CHEMOTHERAPY. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747046 SMARTSITE ADD ON BAG ACCESS DEVICE SET, ADMINISTRATION, INFUSION FPA CAREFUSION 10013361

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR NON-CFN EXT SET,SPIRO ADAPTOR,