BEUDAMED
    FDA Adverse Event Other Summary report: N

    SECURE DUAL CHAMBER TPN BAG

    MDR report key: 743717 · Received June 30, 2006

    Report

    Report Number
    MW1039547
    Event Type
    Other
    Date Received
    June 30, 2006
    Date of Event
    June 28, 2006
    Report Date
    June 29, 2006
    Manufacturer
    THE METRIX COMPANY
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THIS IS THE 5TH DUAL CHAMBER TPN BAG THAT WAS LEAKED UPON TRANSPORTATION IN THE LAST 2 MONTHS. THE BAGS HAVE LEAKED ON THE SIDE SEAMS AND ALSO ON THE SEAM NEAR THE INJECTION PORT. THIS PARTICULAR BAG LEAKED ON THE SIDE SEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURE DUAL CHAMBER TPN BAG STERILE EMPTY CONTAINER KPE THE METRIX COMPANY 58733 58733-1622

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other