BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD

    MDR report key: 7124303 · Received December 15, 2017

    Report

    Report Number
    MW5074053
    Event Type
    Injury
    Date Received
    December 15, 2017
    Date of Event
    November 8, 2017
    Report Date
    December 14, 2017
    Manufacturer
    BARD MEDICAL DIVISION
    Product Code
    KNT
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2017 PRESENTS IN ED WITH ALTERED MENTAL STATUS RELATED TO HEPATIC ENCEPHALOPATHY, LACTULOSE PROTOCOL STARTED AND DIGNISHIELD PLACED FOR PURPOSES OF ADMINISTERING LACTULOSE. ON (B)(6) 2017 AFTER THIRD DOSE OF LACTULOSE (APPROX 1,000 CC EACH) IT WAS NOTED THAT BALLOON WAS OVER-INFLATED AND 900 CCS OF WHAT APPEARED TO BE LACTULOSE WAS WITHDRAWN FROM BALLOON PORT. RECTAL PROLAPSE AND FRANK RECTAL BLEEDING NOTED AFTER BALLOON REMOVAL. COLORECTAL CONSULT WITH NON-SURGICAL REDUCTION OF PROLAPSE (B)(6) 2017 DISCHARGED; (B)(6) 2017 PRE-ADMITTED WITH MASSIVE LOWER GI BLEED REQUIRING SURGERY AND ADMINISTRATION OF BLOOD PRODUCTS. THE INSTALLATION OF LARGE VOLUME MEDICATION INTO THE BALLOON PORT WAS A MEDICATION ADMINISTRATION ERROR BY NURSING. REVIEW OF THE EVENT DID RESULT IN TWO SUGGESTIONS TO MFR WHICH MAY PREVENT USER ERROR OR RESULT IN IMMEDIATE AWARENESS OF ERROR PRIOR TO DAMAGE TO MUCOSA: ALL PORTS ARE LUER LOCK, AND SAFETY MAY BE IMPROVED IF THE BALLOON LOCK IS DIFFERENT TYPE; SOME MFRS HAVE A SAFETY SIGNAL ON BALLOON PORT SO USER CAN IMMEDIATELY SEE THAT OVER-INFLATION HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903156 BARD DIGNISHIELD STOOL MANAGEMENT SYS KNT BARD MEDICAL DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention