BEUDAMED
    FDA Adverse Event Other Summary report: N

    CANISTER GUARDIAN 2000CC W/

    MDR report key: 938422 · Received November 5, 2007

    Report

    Report Number
    1423507-2007-00118
    Event Type
    Other
    Date Received
    November 5, 2007
    Date of Event
    October 9, 2007
    Report Date
    November 5, 2007
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNFORTUNATELY NO PRODUCT SAMPLE WAS AVAILABLE FOR INVESTIGATION. IN ADDITION, NO LOT NUMBER WAS PROVIDED SO THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. A TELEPHONE INTERVIEW WITH SURGICAL MATERIALS BUYER AT THE HOSPITAL WAS CONDUCTED BY CARDINAL HEALTH REPRESENTATIVES ON TUESDAY OCTOBER 16, 2007. THE CONVERSATION REVEALED THAT THE CUSTOMER HAD NOT FOLLOWED THE PRODUCT'S DFU (DIRECTIONS FOR USE). A CARDINAL HEALTH SALES REPRESENTATIVE HAS ALREADY BEEN INVOLVED AND A SECOND IN-SERVICE FOR THE CUSTOMER IS PLANNED.

    Description of Event or Problem · 1

    SIX DIFFERENT STAFF WERE SPRAYED/SPLASHED WITH CONTENTS OF SUCTION CANISTERS DURING THE PROCESS OF DISCONNECTING THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANISTER GUARDIAN 2000CC W/ SUCTION CANISTER KDQ CARDINAL HEALTH 65651-220 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR Required Intervention