BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FENWAL BLOOD RECIPIENT SET

    MDR report key: 610467 · Received June 2, 2005

    Report

    Report Number
    6000001-2005-01835
    Event Type
    Injury
    Date Received
    June 2, 2005
    Date of Event
    April 23, 2005
    Report Date
    May 4, 2005
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    KSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PURCHASING AGENT REPORTS ONE Y-TYPE BLOOD SOLUTION SET IN WHICH THE SPIKE SEPARATED FROM THE TUBING AND THE NURSE WAS SPRAYED WITH BLOOD IN THE MOUTH AND LEFT EYE. THE NURSE SAW THE OPTOMETRIST WHO FLUSHED OUT THEIR EYE. THEY NURSE RECEIVED PRESCRIPTION EYE DROPS. THE NURSE HAD SONE BASELINE TESTING PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FENWAL BLOOD RECIPIENT SET BLOOD SET WITH STANDARD BLOOD FILTER KSB BAXTER HEALTHCARE CORP. NA UR258871

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other