BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK SAFETY INFUSION SYSTEM PUMP SET

    MDR report key: 2640839 · Received May 31, 2012

    Report

    Report Number
    2640839
    Event Type
    Malfunction
    Date Received
    May 31, 2012
    Date of Event
    May 31, 2012
    Report Date
    May 31, 2012
    Manufacturer
    B. BRAUN OF AMERICA, INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    BBRAUN IV TUBING COULD NOT BE PRIMED. UPON FURTHER INVESTIGATION BY RN, AN OBJECT WAS FOUND WITHIN THE TUBING, BLOCKING FLOW OF FLUID. OBJECT IS WHITE AND SMOOTH IN APPEARANCE. OBJECT LOCATED ABOVE THE THIRD INJECTION PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OUTLOOK SAFETY INFUSION SYSTEM PUMP SET INTRAVASCULAR TUBING FPA B. BRAUN OF AMERICA, INC NF3130 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *