BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BBRAUN INFUSOMAT SPACE PUMP LOW ADSORPTION SET

    MDR report key: 2843467 · Received September 25, 2012

    Report

    Report Number
    2843467
    Event Type
    Malfunction
    Date Received
    September 25, 2012
    Date of Event
    September 3, 2012
    Report Date
    September 25, 2012
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    HANGING CHEMOTHERAPY (AVASTIN) AND SPIKE SLIPPED OUT OF BAG, ALLOWING CONTENTS TO SPLASH ACROSS LEFT FOREHEAD, EYE LID, CHEEK, LIP AND DOWN NECK OF NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BBRAUN INFUSOMAT SPACE PUMP LOW ADSORPTION SET SET, ADMINISTRATION, INTRAVASCULAR FPA B. BRAUN MEDICAL INC. * 0061246685 OR 0061254106
    2 BBRAUN 0.9% SODIUM CHLORIDE INJECTION, 100ML PARTIAL FILL CONTAINER, IV KPE B.BRAUN MEDICAL, INC. * J2J926 OR J2H937

    Patients

    Seq Age Sex Outcome Treatment
    1 * CHEMOTHERAPY