MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. G-JET; LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING DEVICE

Model Number	GJ-1430-45
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Per the original reporter in uf #(b)(4): , it was reported that "this registered nurse (rn) was passed along information in report that patient's gj tube was dislodged.Was told patient had increased agitation and movement early in the morning and rn entered into the room to administer medications and gj tube was dislodged.Rn paged team to the bedside and doctor came to the bedside to assess and placed orders.Showed malfunction of gj tube balloon.Patient to return to or to have gj tube replaced as this is a surgical procedure.".
Additional Manufacturer Narrative
This report is a response to mdr report # (b)(4) which was received by amt from the fda on 02/20/2024.Based on the provided information, the complaint is not a reportable event per 21 cfr section 803.There was no death.There was no serious injury as defined by the fda.This was not life-threatening, nor did this result in permanent impairment or necessitate medical or surgical intervention to preclude permanent impairment.Amt reached out to the reporter to gather additional information regarding the complaint and to see if the device is available for return.At the time of this report there has been no response to the availability of the device.Due to this, a visual and functional evaluation could not be performed, and device failure could not be confirmed.Based on the provided information, the reported complaint is not believed to have been caused by a manufacturing defect.A complaint has been logged in our system to track this record in complaint #: (b)(4) and will be used for trend analysis.

• Brand Name: G-JET
• Common Device Name: LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING DEVICE
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville OH 44141
• Manufacturer (Section G): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville OH 44141
• Manufacturer Contact: ellyn smith ; 8006 katherine boulevard; brecksville, OH 44141
• MDR Report Key: 18943636
• Report Number: 1526012-2024-00005
• Device Sequence Number: 14167622
• Product Code: KNT
• UDI-Device Identifier: 00842071101824
• UDI-Public: 00842071101824
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GJ-1430-45
• Device Catalogue Number: GJ-1430-45
• Device Lot Number: 200827-189
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Sex: Male