BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALL IN ONE CONTAINER

    MDR report key: 542536 · Received September 8, 2004

    Report

    Report Number
    6000001-2004-01412
    Event Type
    Other
    Date Received
    September 8, 2004
    Date of Event
    September 1, 2002
    Report Date
    September 27, 2002
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    KPE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED "LEAKING BAGS" AND STATED THAT THEY HAD THREE CASES OF "IN-LINE INFECTION". NO OTHER DETAILS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALL IN ONE CONTAINER COMPOUNDING CONTAINER KPE BAXTER HEALTHCARE CORP. NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other