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 Separation (1562)
Health Effect - Clinical Code	Vomiting (2144)
Date of Event	12/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated that "the tube was clogged and mom was flushing water using a syringe.She felt it unclog, but later that night the patient vomited up the blue tube portion of the gj (jejunal tubing).The balloon was still intact".No harm was reported to the patient.
Additional Manufacturer Narrative
This complaint was originally reported to amt on 12/28/2023.There was no information provided that a death, serious injury, or any other harm occurred with the patient.A report is being sent to fda as a portion of the device was thrown up by the patient.The information provided by the patient is that they were putting water through the tube to clear a clog, felt the tube unclog, but the patient threw up the blue tube portion later that night.The examination of the device found that the jejunal tube section had separated from the external body, with signs of residue and clogging noted with 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 separated the internal tube from the rest 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.The device was in use for roughly one month before the failure occurred, indicating that the device was properly functioning during this time.We have assigned complaint # (b)(4) to this record.

• 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: joshua meinke ; 8006 katherine boulevard; brecksville, OH 44141 ; 4407174000
• MDR Report Key: 18589940
• Report Number: 1526012-2024-00001
• Device Sequence Number: 7030833
• 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
• 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): 01/26/2024

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: 230706-089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2023
• Initial Report FDA Received Date: 01/26/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown