BEUDAMED
    FDA Adverse Event Other Summary report: N

    KIT, PLEURX DRAINAGE 10/CS

    MDR report key: 1351727 · Received March 25, 2009

    Report

    Report Number
    1423507-2009-00037
    Event Type
    Other
    Date Received
    March 25, 2009
    Date of Event
    February 24, 2009
    Report Date
    March 24, 2009
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNFORTUNATELY, AS NO LOT NUMBER WAS REPORTED, THE DHR (DEVICE HISTORY RECORD) COULD NOT BE REVIEWED. ALSO, NO PRODUCT SAMPLE WAS PROVIDED FOR EVALUATION. THE MANUFACTURING PROCESS AND MATERIALS RECORDS WERE REVIEWED AND THERE WAS NO INDICATION THAT EITHER WAS RELATED TO THE PROBLEM REPORTED. CONSEQUENTLY, WE ARE UNABLE TO DETERMINE A ROOT CAUSE OF THE REPORTED PROBLEM. CARDINAL HEALTH IS MOVING TOWARD A NEW DESIGN OF THE 500 ML DRAINAGE BOTTLE THAT WILL FACILITATE THE WASTE DISPOSAL PROCESS.

    Description of Event or Problem · 1

    NURSE REPORTED SPLASH-BACK OF PLEURAL FLUID INTO EYE WHILE CUTTING THE GREEN TUBE TO DUMP THE FLUID. NURSE REPORTED TO ME THAT THE PATIENT WAS "HIGH RISK" AND "(B) (6) POSITIVE". SHE VOICED EXPECTATION OF A RETURN CALL AFTER THIS REPORT IS FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIT, PLEURX DRAINAGE 10/CS PLEURAL CATHETER DRAINAGE KIT KDQ CARDINAL HEALTH 50-7500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention