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

Model Number	MGJ-1417-30-I
Medical Device Problem Codes	Increase in Pressure (1491); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was originally reported to amt on 01/11/2024 by (b)(6) of (b)(6) medical center.The device was then returned for inspection and analyized.On (b)(6) 2024, amt was notified of a medwatch report regarding this device.There was no information provided that a death, serious injury, or any other harm occurred with the patient.A response is being sent to fda as the incident was reported under medwatch report #(b)(4).The information provided by the patient is that the tube clogged and when they went to use the tube, a hole formed in the sillicone stoma portion of the device.The examination of the device found that the jejunal tube section had shifted down in the external body, with signs of residue and clogging noted within the external bolster and tubing areas.It was concluded that in attempts to clear a tough clog through the tube, the user increased pressure inside of the tube high enough that it pushed the internal tube down, tearing part of the device.Based on the provided information and examination of the device, there was no evidence found that would indicate the failure was due to a manufacturing defect or quality issue.We have assigned the internal complaint # (b)(4) to this record.
Event or Problem Description
Per the original reporter in uf #: (b)(4), it was reported that an "amt micro g-jet 1.7cm x 30cm gj tube clogged and when family tried to use tube, tube broke above balloon creating a hole.Patient came in and tube was exchanged".No harm was reported to the patient.

• Brand Name: MICRO G-JET
• Common Device Name: LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE
• 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 ; 4402622539
• MDR Report Key: 18961701
• Report Number: 1526012-2024-00006
• Device Sequence Number: 7965866
• Product Code: KNT
• UDI-Device Identifier: 00842071124885
• UDI-Public: 00842071124885
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K183508
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/22/2024

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: Lay User/Patient
• Device Model Number: MGJ-1417-30-I
• Device Catalogue Number: MGJ-1417-30-I
• Device Lot Number: 231209-053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown