MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. MINI ONE® BALLOON BUTTON; LOW PROFILE FEEDING DEVICE

Model Number	M1-5-1417-I
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is a response to medsun report # (b)(4) which was received by amt from the fda on 02/27/2026.The occurrence was originally reported to amt on 02/23/2026 by the same initial reporter.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 worked with the original reporter to obtain the device for examination and performed an inspection of the device once returned.Examination of the device was able to confirm the reported complaint that there was leakage from the device.A small amount of residue was found in the one-way duckbill valve, preventing it from fully closing.Once the residue was removed by flushing the valve no longer leaked.Recent trending data shows no anomalies in reported failures from the field.A device history review found no similar complaints have been reported for the same manufacturing batch.The complaint information has been logged into our complaint database for trending purposes.Information regarding device investigation can be found under complaint # (b)(4).
Event or Problem Description
Per the original reporter in medsun report #: (b)(4), it was reported that, "we did a g-tube exchange because the g-tube that was previously placed on [redacted] per md was malfunctioned and had a leak in the middle of the tube, causing leakage".

• Brand Name: MINI ONE® BALLOON BUTTON
• Common Device Name: LOW PROFILE 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 dipaolo ; 8006 katherine boulevard; brecksville, OH 44141 ; 4402622539
• MDR Report Key: 24713034
• Report Number: 1526012-2026-00005
• Device Sequence Number: 5677088
• Product Code: KNT
• UDI-Device Identifier: 00842071140830
• UDI-Public: 00842071140830
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K161413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 03/27/2026

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: M1-5-1417-I
• Device Catalogue Number: M1-5-1417-I
• Device Lot Number: 250925-530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/30/2026
• 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: Female