BEUDAMED
    FDA Adverse Event Other Summary report: N

    B BRAUN

    MDR report key: 746516 · Received October 6, 2005

    Report

    Report Number
    MW1036843
    Event Type
    Other
    Date Received
    October 6, 2005
    Date of Event
    September 22, 2005
    Report Date
    October 5, 2005
    Manufacturer
    B BRAUN MEDICAL, INC.
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    B BRAUN HAS RECENTLY CHANGED FROM PVC TO EVA FOR THEIR 3 IN 1 TPN MIXING CONTAINER. - PROD# S9991-10. A HEAT-SEALED LEAD LINE FAILED WITHIN 12 HOURS, WASTING MORE THAN $2,000 WORTH OF MEDICATION AND DELAYING THERAPY. WE HAD NO FAILURES WITH PVC. GOING FORWARD, THESE LINES WILL BE METAL CLAMPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B BRAUN 3 IN 1 EVA MIXING CONTAINER KPE B BRAUN MEDICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other