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

Model Number	M1-5-1410-I
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2025
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 07/15/2025.The complaint was originally reported to amt on (b)(6) 2025 by (b)(6).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.The reporter indicated that the device referenced in the report is not available for return.Since the device was not returned, a visual and functional evaluation could not be performed, and device failure cannot be confirmed at this time.A device history review was completed for the reported lot number and no anomalies were found and there have been no other complaints from other users regarding tears or ruptures from this same batch.The complaint information has been logged into our complaint database for trending purposes.Complaint #(b)(4) was assigned to this report for internal trending.
Event or Problem Description
Per the original reporter in uf report #: (b)(4), it was reported that, "called to bedside by rn because she noted increased space between skin and base of g-tube, and ease of movement with dressing cares.Called surgical app [advanced practice provider] on call.She recommended obtaining dye study and making infant npo if any concerns with g-tube, said she would come up but also that she was managing trauma and would likely see in am.We obtained dye study, normal within tract.Bedside rn, charge rn, md and myself (app) checked if there was any fluid within g-tube balloon, met resistance and were unable to pull anything off balloon.Checked or [operating room] report, initially had 4cc of water in balloon.Re-instilled 0.5cc of water before meeting resistance.Very likely based on exam that balloon had been ruptured and this is why there was increased movement in g-tube, despite maintained within tract.I called surgical app and made aware of findings regarding balloon, normal dye study and making infant npo [nil per os].She said they would see infant in am.G-tube replaced finally on [date redacted] and surgical team noted g-tube balloon had been ruptured.Per previous patients, this is one of multiple recent g-tubes with issues regarding balloon integrity".

• Brand Name: MINI ONE BALLOON BUTTON
• Common Device Name: LOW PROFILE 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: 22752517
• Report Number: 1526012-2025-00012
• Device Sequence Number: 8715900
• Product Code: KNT
• UDI-Device Identifier: 00842071140779
• UDI-Public: 00842071140779
• 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
• 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): 08/08/2025

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: Health Professional
• Device Model Number: M1-5-1410-I
• Device Catalogue Number: M1-5-1410-I
• Device Lot Number: 250326-205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 08/08/2025
• 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: 2 MO
• Patient Sex: Male