BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE-LINK

    MDR report key: 2875144 · Received October 11, 2012

    Report

    Report Number
    2875144
    Event Type
    Malfunction
    Date Received
    October 11, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 11, 2012
    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

    DISTRIBUTION TECHNICIAN OBSERVED BADLY FADED / ILLEGIBLE LABEL ON FIVE INDIVIDUALLY PACKAGED STERILE EXPANSION SETS. TECHNICIAN REMOVED PRODUCT WITH DEFECTIVE LABEL FROM CHANNEL OF DISTRIBUTION. VENDOR IS BEING NOTIFIED. TECHNICIAN INSPECTED REMAINING PRODUCT FOR ADEQUACY OF LABEL. NO OTHER DEFECTS FOUND.NO ADVERSE EVENT SINCE PRODUCT NEVER REACHED PATIENT CARE AREAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE-LINK SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION * UR12H15148

    Patients

    Seq Age Sex Outcome Treatment
    1 *