BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINER SUCTION 1500CC

    MDR report key: 1896848 · Received November 11, 2010

    Report

    Report Number
    1423537-2010-00059
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    September 29, 2010
    Report Date
    November 11, 2010
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS PROVIDED BY THE CUSTOMER; THEREFORE AN EVALUATION OF THE COMPLAINT DEVICE FOR DEFICIENCY OF CONSTRUCTION COULD NOT BE PERFORMED. WITHOUT THE SAMPLE, NO POSITIVE CONCLUSION CAN BE MADE REGARDING THE CAUSE OF THE CUSTOMER CONCERN.

    Description of Event or Problem · 1

    WHILE DOING A TERMINAL CLEAN IN OPERATING ROOM 1, I WENT TO CHANGE THE CANISTER AND THE BLOOD AND BODY FLUID SPLASHED ALL OVER MY FACE AND CHEST. THIS EMPLOYEE WAS SEEN AT (B)(6) AND BEGAN POST-EXPOSURE PROPHYLACTIC MEDICATION. SOURCE PATIENT WAS TESTED, AND NEGATIVE FOR (B)(6), (B)(6) AND (B)(6). THIS EMPLOYEE'S LABS WERE WNL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINER SUCTION 1500CC SUCTION CANISTER LINER GCX CARDINAL HEALTH 65651-920C NO LOT GIVEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention