BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXI-SEAL SIGNAL FMS (1X1PK) US

    MDR report key: 4336635 · Received December 8, 2014

    Report

    Report Number
    1049092-2014-00603
    Event Type
    Death
    Date Received
    December 8, 2014
    Date of Event
    November 1, 2014
    Report Date
    November 12, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THE EVENT IS DEEMED TO BE A DEATH. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFO BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A NURSE REPORTED THE DEVICE HAD BEEN PREVIOUSLY INSERTED INTO THE PT'S RECTUM ON AN UNK DATE. WHILE ADMINISTERING A LACTULOSE MEDICATION SOLUTION, THE NURSE INADVERTENTLY INSTILLED 500 MILLILITERS THE SOLUTION INTO THE BALLOON INFLATION PORT RATHER THAN THROUGH THE IRRIGATION PORT. THE PT REPORTEDLY EXPIRED ON AN UNK DATE. THE CAUSE OF DEATH WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789344 FLEXI-SEAL SIGNAL FMS (1X1PK) US GASTROINTESTINAL TUBE AND ACCESSORIES KNT CONVATEC, INC. 418000

    Patients

    Seq Age Sex Outcome Treatment
    1 Death