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

Model Number	MGJ-1410-22-I
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Per the original reporter in medsun report #: (b)(4), it was reported that the "patient has a g-tube and a gastrojejunostomy (gj) that both go through the same site.During the reporting caregivers first set of cares with the patient, he noticed that one of the connections at the end of the g-tube was broken (part of the plastic was broken off)".
Additional Manufacturer Narrative
This report is a response to report medsun # (b)(4) which was received by amt from the fda on 02/04/2025.Based on the information provided, the incident 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.The reporter initially reported the event to amt on 01/14/2025, stating that the event occurred on 01/05/2025.At this time the reporter indicated that the device was available for examination and that the failure occurred with a 6-1222-isosaf gastric extension set.Since the reporter states extension sets are not stocked separately at the user facility, it is believed that the failed extension set was part of the micro g-jet device kit.Though no extension set lot information could be provided to confirm this.The reporter clarified that, "the y shaped connection of the extension tubing, where you attach syringes broke".Amt reached out to the reporter in attempts to retrieve the device for examination but received no response.Since the device was not returned, a visual and functional evaluation could not be performed, and device failure could not be confirmed.In the event the device is returned at a later date, there will be no change to the non-reportability of this case based on the device investigation.A device history review found no defects and no similar complaints have been reported from the same manufactured batch.Based on the information provided the reported problem is not believed to have been caused by a manufacturing defect.Complaint # (b)(4) was assigned to this report.

• 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: 21517214
• Report Number: 1526012-2025-00002
• Device Sequence Number: 12846930
• Product Code: KNT
• UDI-Device Identifier: 00842071124755
• UDI-Public: 00842071124755
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K183508
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/04/2025

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: Other
• Device Model Number: MGJ-1410-22-I
• Device Catalogue Number: MGJ-1410-22-I
• Device Lot Number: 231229-106
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 2 MO
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White