BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B/BRAUN 3-IN-1 MIXING CONT

    MDR report key: 492319 · Received October 14, 2003

    Report

    Report Number
    MW1029876
    Event Type
    Malfunction
    Date Received
    October 14, 2003
    Date of Event
    October 8, 2003
    Report Date
    October 8, 2003
    Manufacturer
    B.BRAUN MEDICAL, INC.
    Product Code
    MYJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    WHILE FILLING 1000 ML 3:1 MIXING CONTAINER WITH TPN SOLUTION THE TECH NOTICED MATERIAL IMBEDDED IN THE PLASTIC OF THE HYPER FORMER FILLING PORT. WHEN FILLED WITH LIPID TPN THE FOREIGN MATERIAL WAS MADE MORE VISIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B/BRAUN 3-IN-1 MIXING CONT 3:1 MIXING CONTAINER 1000 ML MYJ B.BRAUN MEDICAL, INC. * 060461837

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other