BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G-JET

    MDR report key: 4091674 · Received July 31, 2014

    Report

    Report Number
    4091674
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 31, 2014
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE MOTHER OF THE PATIENT NOTIFIED RN THAT THE GASTRIC-JEJUNAL (G-J)TUBE WAS LEAKING AT THE EXTENSION CONNECTION SITE. THE CAP WOULD NOT SNAP IN TIGHT AND REQUIRED TAPING TO KEEP IT IN PLACE. IT APPEARS THAT THE GASTRIC PORT FITTING CAME FREE FROM THE FOUR (4) SILICON ANCHORS ON THE G-J TUBE HOUSING. THE JEJUNAL PORT WAS NOT BROKEN AS IT IS FIRMLY AFFIXED INTERNALLY TO THE JEJUNAL LUMEN.THE PATIENT NEEDED TO BE HOSPITALIZED 3 EXTRA DAYS IN ORDER TOSCHEDULE AN APPOINTMENT IN INTERVENTIONAL RADIOLOGY (IR) TO REPLACE THE TUBE. IR HAD TO SPECIAL ORDER THE TUBE AND HAVE IT DROP SHIPPED TO THE HOSPITAL. THIS IS THE ONLY WAY PATIENT RECEIVES NUTRITIONAL SUPPORT.====================== MANUFACTURER RESPONSE FOR GASTRIC-JEJUNAL (G-J) ENTERAL TUBE, AMT G-JET- LOW PROFILE GASTRIC-JEJUNAL ENTERAL TUBE (PER SITE REPORTER)======================AS OF THIS REPORT, NO RESPONSE HAS BEEN GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449207 G-JET TUBE, GASTROINTESTINAL KNT APPLIED MEDICAL TECHNOLOGY, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR RIGHT-ANGLE FEEDING SET