BEUDAMED
    FDA Adverse Event Summary report: N

    G-JET LOW PROFILE GASTRIC-JEJUNAL ENTERAL TUBE

    MDR report key: 4929780 · Received July 17, 2015

    Report

    Report Number
    1526012-2015-00002
    Date Received
    July 17, 2015
    Date of Event
    December 11, 2014
    Report Date
    May 7, 2015
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    PMA / PMN Number
    K123716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS FOUND IN THE MAUDE DATABASE ON (B)(6)-2015, THE USER FACILITY IS UNKNOWN, AND AMT HAS NOT RECEIVED ANY DIRECT INFORMATION. THE DEVICE WAS NOT RETURNED FOR INSPECTION, SO AN ANALYSIS OF THE DEVICE COULD NOT BE PERFORMED. BASED ON A REVIEW OF THE LIMITED INFORMATION, IT IS NOT BELIEVED THAT THE DEVICE CAUSED THE PERFORATION. DEPENDING ON THE INSERTION METHOD, THE PERFORATION COULD HAVE BEEN CAUSED DURING INSERTION BY A GUIDEWIRE OR ENDOSCOPE, AND NOT THE SOFT FLEXIBLE TIP OF THE GJ DEVICE. IT IS NOT BELIEVED THAT THE DEVICE MALFUNCTIONED. THE TUBING OF THE DEVICE IS MADE OF A SOFT SILICONE RUBBER, WHICH WOULD NOT CAUSE A PERFORATION BY ITSELF IT CORRECTLY PLACED. THE LOT NUMBER WAS NOT PROVIDED, SO A DHR REVIEW COULD NOT BE COMPLETED AND THE DEVICE WAS NOT RETURNED TO AMT FOR ANALYSIS. WE WILL PROVIDE ADDITIONAL INFORMATION TO THE FDA IF THE DEVICE OR ADDITIONAL INFORMATION IS ABLE TO BE OBTAINED AND ITS ANALYSIS CHANGES THE CONCLUSION OF THIS REPORT. WE HAVE ASSIGNED COMPLAINT NUMBER (B)(4) TO THIS REPORT.

    Description of Event or Problem · 1

    EVENT DESCRIPTION: PERFORATION OF SMALL BOWEL ADJACENT TO TIP OF THE GASTROJEJUNAL FEEDING TUBE, CONFIRMED AT SURGERY. DEVELOPED PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464648 G-JET LOW PROFILE GASTRIC-JEJUNAL ENTERAL TUBE GASTRIC-JEJUNAL ENTERAL TUBE KNT APPLIED MEDICAL TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention