BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL SECONDARY SET

    MDR report key: 2468943 · Received February 17, 2012

    Report

    Report Number
    2468943
    Event Type
    Malfunction
    Date Received
    February 17, 2012
    Date of Event
    February 15, 2012
    Report Date
    February 17, 2012
    Manufacturer
    CODAN US CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    WHEN RN PREPARING TO HANG CASPOFUNGIN, NOTED MEDICATION LEAKING OUT OF TUBING. ON INSPECTION, TUBING NOTED TO HAVE A SLICE OR CUT IN IT APPROXIMATELY 12 1/2 INCHES BELOW THE DRIP CHAMBER. NEW TUBING OBTAINED. DISCOVERED BEFORE TAKEN INTO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL SECONDARY SET INTRAVASCULAR TUBING FPA CODAN US CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *