BEUDAMED
    FDA Adverse Event Death Summary report: N

    MOSS GASTROSTOMY TUBE

    MDR report key: 290917 · Received August 16, 2000

    Report

    Report Number
    1320599-2000-00001
    Event Type
    Death
    Date Received
    August 16, 2000
    Date of Event
    July 20, 2000
    Report Date
    August 8, 2000
    Manufacturer
    MOSS TUBES, INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2000, A MOSS GASTROSTOMY TUBE WAS PLACED, BY A MD AT THE HOSP, INTO A PT. THE MD ORDERED CONTINUOUS GRAVITY SUCTION, CONTRARY TO PRODUCT INSTRUCTION, WHICH DIRECTS 35-70 MM CONTINUOUS SUCTION. ADDITIONALLY, THE TUBE WAS INCORRECTLY CONNECTED, HAVING THE FEEDING BAG CONNECTED TO THE SUCTION CHANNEL. ON JULY 20 THE PT EXPIRED AND THE MISUSE OF THE TUBE WAS DISCOVERED. THE THREE PORTS ARE VASTLY DIFFERENT IN SIZE. THE TUBE COULD NOT HAVE FUNCTIONED AS DESIGNED UNDER SUCH CONDITIONS. THE INSTRUCTIONS PROVIDED WITH THE TUBE DIRECT THAT THE ASPIRATION CHANNEL BE IRRIGATED WITH A 60CC BOLUS OF WARM SALINE EVERY 2 HRS. THERE IS NO MENTION IN THE HOSP REPORT THAT THIS PROTOCOL WAS PERFORMED. SAID PROCEDURE WOULD HAVE REVEALED THE INCORRECT USE OF THE TUBE. THE HOSP HAS PURCHASED AND USED 70 MOSS GASTROSTOMY TUBES PRIOR TO THIS EVENT. THE DESIGN AND CONSTRUCTION OF THE TUBE DID NOT CONTRIBUTE TO THE ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOSS GASTROSTOMY TUBE GASTROSTOMY/SUCTION TUBE KNT MOSS TUBES, INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death WITH PREATTACHED FLEXIFLO COMPANION PUMP SET.| FLEXIFLOW TOPTAINER ENTERAL NUTRITIO CONTAINER,