BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION PCA TUBING

    MDR report key: 6331500 · Received February 15, 2017

    Report

    Report Number
    6331500
    Event Type
    Malfunction
    Date Received
    February 15, 2017
    Date of Event
    November 3, 2016
    Report Date
    November 10, 2016
    Manufacturer
    CAREFUSION 211, INC.. DBA CAREFUSION
    Product Code
    FPK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENTS IV TUBING FOUND TO BE LEAKING. ASSESSED TUBING AND DETERMINED THAT IT WAS THE PCA TUBING LEAKING. CRACK FOUND IN HARD PLASTIC CONNECTOR END OF TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116699 CAREFUSION PCA TUBING TUBING, FLUID DELIVERY FPK CAREFUSION 211, INC.. DBA CAREFUSION 11611800

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR