BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSITE VIALSHIELD

    MDR report key: 5001725 · Received August 13, 2015

    Report

    Report Number
    9616066-2015-00966
    Event Type
    Injury
    Date Received
    August 13, 2015
    Date of Event
    April 8, 2015
    Report Date
    July 15, 2015
    Manufacturer
    CAREFUSION
    Product Code
    LHI
    PMA / PMN Number
    K132863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PACLITAXEL 300MG/ML VIAL, LOT NUMBER 14J16NA, MANUFACTURER TEVA; THERAPY DATE (B)(6) 2015. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED DUE TO THE PRODUCT WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED. THIS PRODUCT IS DISTRIBUTED BY (B)(4) AND MANUFACTURED BY YUKON MEDICAL. (B)(4)

    Description of Event or Problem · 1

    WE RECEIVED MAUDE REPORT FROM YUKON MEDICAL THAT THE FDA PROVIDED TO THEM THAT STATED, "CAREFUSION SMARTSITE VIALSHIELD 20MM CLOSED VIAL ACCESS DEVICE (#1) FAILED TO COMPLETELY PENETRATE THE STOPPER OF THE TEVA PACLITAXEL 300MG/50ML VIAL (#2). THE VIALSHIELD AND PACLITAXEL VIAL WHERE PLACED IN THE CONNECTING APPARATUS PROVIDED BY (B)(4). THE LEVEL WAS PULLED DOWN TO ACTIVATE THE CONNECTION INSTRUCTED BY (B)(4). HOWEVER, THE VIALSHIELD FAILED TO COMPLETELY PENETRATE THE VIAL STOPPER. INSTEAD, THE VIALSHIELD PUSH THE VIAL STOPPER DOWN INTO THE VIAL. TO MINIMIZE EXPOSURE TO PACLITAXEL, THE HAZARDOUS CONTENTS OF VIAL WERE DRAWN UP INTO A 60ML SYRINGE AND CALLED WITH A TEVADAPTOR SYRINGE ADAPTOR." THERE IS NO REPORT OF USER OR PATIENT HARM; THE EVENT OUTCOME IS LISTED AS REQUIRED INTERVENTION BUT THERE IS NO DETAIL PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536652 SMARTSITE VIALSHIELD SET, I.V. FLUID TRANSFER23 LHI CAREFUSION MV0520 4241

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention