BEUDAMED
    FDA Adverse Event Summary report: N

    SMARTGOWN, XLRG, XLNG, A-LINE

    MDR report key: 1870077 · Received September 30, 2010

    Report

    Report Number
    1423537-2010-00044
    Date Received
    September 30, 2010
    Date of Event
    August 19, 2010
    Report Date
    September 30, 2010
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO LOT NUMBER WAS PROVIDED, THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE CUSTOMER DID NOT RESPOND TO REQUESTS FOR INFORMATION ABOUT THE INCIDENT. THE SAMPLE WAS REC'D AND EVALUATED. THE OUTSIDE OF THE GOWN SHOWED BLOOD/FLUID SPOTS AT THE CHEST AREA. IN THE INSIDE, ONLY SHOWTHROUGH NOT STRIKETHROUGH WAS FOUND. THE LEFT SLEEVE HAD HEAVY BLOOD/FLUID CHALLENGE FROM THE ELBOW TO THE WRIST AREA, AS WELL AS THE CUFF BEING COMPLETELY SATURATED WITH BLOOD/FLUID. SHOWTHROUGH (NOT STRIKETHROUGH), WAS OBSERVED ON THE INSIDE OF THE SLEEVE. THE SLEEVE SEAL WAS INTACT. THE INSIDE OF THE GOWN SLEEVE WAS TESTED WITH AN ALCOHOL PAD TO CONFIRM STRIKETHROUGH, AND THE TEST RESULT WAS NEGATIVE. BASED ON THE REVIEW OF THE SAMPLE, IT APPEARED THAT THE BLOOD CHALLENGE DID NOT PENETRATE THROUGH THE ACTUAL GOWN SLEEVE MATERIAL, BUT WAS DUE TO THE CUFF BEING COMPLETELY SATURATED WITH BLOOD/FLUID, AND THE BLOOD/FLUID WICKING UP AT THE CUFF LINE TO THE INSIDE OF THE SLEEVE. THIS ISSUE COULD BE CAUSED BY THE GLOVE SLIDING DOWN AND/OR CHANNELING OF FLUID. WE WILL CONTINUE TO MONITOR FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 1

    STRIKETHROUGH REPORTED ON THE SURGEON'S WRISTS WHEN THE GOWN WAS REMOVED. (B)(6). SURGEON CLEANED HANDS AND ARMS IMMEDIATELY, AND APPARENTLY WAS TESTED AND CLEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTGOWN, XLRG, XLNG, A-LINE SURGICAL GOWN/FYA KKX CARDINAL HEALTH NO LOT GIVEN

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other