BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE-FLOW 275

    MDR report key: 1055500 · Received May 30, 2008

    Report

    Report Number
    MW5007104
    Event Type
    Malfunction
    Date Received
    May 30, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 30, 2008
    Manufacturer
    WOO YOUNG MEDICAL CO., LTD
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    INFUSOR DEVICE MFG BY WOO YOUNG MEDICAL CO. LTD FAILED TO DELIVER CHEMOTHERAPY CONTINUOUS INFUSION. DESCRIPTION OF DEVICE : MODEL # C0015L; VOLUME: 275 ML; FLOW RATE: 1.5ML/HR; LOT #: CCLHS88; M.F.D AUG 29, 2007. DATES OF USE 2008. DIAGNOSIS: CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURE-FLOW 275 INFUSOR FRN WOO YOUNG MEDICAL CO., LTD CCOO15L CCLHS88

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other