BEUDAMED
    FDA Adverse Event Other Summary report: N

    G-JET

    MDR report key: 4185816 · Received October 16, 2014

    Report

    Report Number
    1526012-2014-00001
    Event Type
    Other
    Date Received
    October 16, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 31, 2014
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    PMA / PMN Number
    K123716
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AMT RECEIVED THE DEVICE IN QUESTION ON (B)(6) 2014. THE COMPLAINT INFO WAS ANALYZED AND THE DEVICE WAS EXAMINED. IT WAS DETERMINED THAT THE DEVICE DID NOT FAIL DUE TO A MFG DEFECT. IT WAS ALSO DETERMINED THAT THE DEVICE WAS NOT A REPORTABLE EVENT ACCORDING TO FDA'S DEFINITION OF REPORTABLE EVENT. THE COMPLAINT WAS CLOSED ON (B)(6) 2014. ON (B)(6) 2014, AMT RECEIVED A MEDWATCH REPORT FROM FDA THAT WAS FILLED OUT BY THE USER FACILITY. THE INFO DID NOT PROVIDE ANY ADDITIONAL DETAILS THAT WOULD MAKE THE FAILURE OF THE DEVICE A REPORTABLE EVENT. AMT HAS UPDATED OUR COMPLAINT REPORT TO INCLUDE REF. TO THE MEDWATCH REPORT AND TO PROVIDE FURTHER RATIONALE FOR WHY THE COMPLAINT IS NOT A REPORTABLE EVENT. OVERALL, THE DEVICE DID NOT CAUSE A SERIOUS INJURY OR DEATH, AND DID NOT MALFUNCTION IN A WAY THAT COULD LEAD TO A SERIOUS INJURY OR DEATH. AMT SELLS DISPOSABLE FEEDING TUBES THAT REQUIRE PERIODIC REPLACEMENT. DEVICE LONGEVITY WILL DEPEND ON PT AND ENVIRONMENT FACTORS. THE USER OF THE DEVICE WAS NOT HARMED AND PERIODIC REPLACEMENT IS REQUIRED FOR ALL JEJUNAL FEEDING DEVICES, REGARDLESS OF THE MFR. THE PT WAS ONLY HOSPITALIZED BECAUSE THE HOSPITAL DID NOT SUFFICIENT STOCK OF THE DEVICE ON HAND, NOT TO PREVENT SERIOUS INJURY OR DEATH. HOSPITALIZATION WHILE WAITING FOR A NEW DEVICE WAS NOT NECESSARY AS THE CONDITION OF THE DEVICE WOULD HAVE ALLOWED THE DEVICE TO STILL FUNCTION FOR JEJUNAL FEEDINGS FOR THE SEVERAL DAYS THE PT WAITED FOR A NEW DEVICE. AMT CONCLUDES THAT THIS IS NOT A REPORTABLE EVENT, AS PER FDA'S DEFINITION AND THE REPORTED DETAILS OF THE COMPLAINT.

    Description of Event or Problem · 1

    TITLE: XXXX. EVENT DESC: THE MOTHER OF THE PT 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 PT NEEDED TO BE HOSPITALIZED 3 EXTRA DAYS IN ORDER TO SCHEDULE 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 PT RECEIVES NUTRITIONAL SUPPORT. MFR RESPONSE FOR GASTRIC JEJUNAL (G-J) ENTERAL TUBE, AMT G-JET LOW PROFILE GASTRIC-JEJUNAL ENTERAL TUBE (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656681 G-JET TUBE, GASTROINTESTINAL KNT APPLIED MEDICAL TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 1.0 YR Other RIGHT-ANGLE FEEDING SET