BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2081169 · Received April 27, 2011

    Report

    Report Number
    2081169
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 27, 2011
    Report Date
    April 27, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US

    Narratives

    Description of Event or Problem · 1

    NURSE OBSERVED A PIN HOLE LEAK IN IV TUBING; REMOVED SET FROM USE AND REPLACED WITH A NEW SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * INTRAVASCULAR SET FPA BAXTER HEALTHCARE CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *