BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 753091 · Received June 16, 2005

    Report

    Report Number
    MW1035776
    Event Type
    Other
    Date Received
    June 16, 2005
    Date of Event
    June 14, 2005
    Report Date
    June 16, 2005
    Manufacturer
    B BRAUN
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SIX TOTAL-3 LIER DUAL CHAMBER BAGS-LEAKS NOTED AT LIPID AND NON LIPID STEM SEALS WHILE TECHNCIAN FILLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * 3 LITER DUAL CHAMBER TPN BAGS KPE B BRAUN * 4/51111

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other