BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD Q-SYTE 6" SMALL BORE EXTENSION SET

    MDR report key: 4279010 · Received November 19, 2014

    Report

    Report Number
    2243072-2014-00291
    Event Type
    Injury
    Date Received
    November 19, 2014
    Date of Event
    November 12, 2014
    Report Date
    November 19, 2014
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD Q-SYTE SMALL BORE EXTENSION SET WAS PLACED ON A PATIENT'S BARD PICC LINE. THE PATIENT WAS RECEIVING THE CHEMOTHERAPY DRUG KABIVEN THROUGH THE PICC LINE. THE PICC LINE WAS USED FOR SEVEN DAYS AND AT THE END OF THAT TIME THE CLINICAL STAFF AT THE HOSPITAL WHERE THE PATIENT WAS RECEIVING TREATMENT WAS UNABLE TO REMOVE THE BD Q-SYTE FROM THE PICC LINE. THIS RESULTED IN THE PICC LINE HAVING TO BE REMOVED AND A NEW PICC LINE WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750405 BD Q-SYTE 6" SMALL BORE EXTENSION SET LUER ACCESS SPLIT-SEPTUM DEVICE FPA BECTON DICKINSON 4006378

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention