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

Model Number	M1-5-1210-I
Medical Device Problem Codes	No Apparent Adverse Event (3189); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Distress (2329); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is a response to medwatch report # mw5170433 which was received by amt from the fda on 05/29/2025.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 a tear occurred at the distal end of the balloon allowing water to leak out.However, contrary to the reporter's claim that the devices failed due to a manufacturing defect, the investigation of the returned device did not find any indication that a manufacturing defect led to the device failure.Note that a spare device should be kept on hand in the event a device exchange is needed prior to scheduled replacement.Having a spare device prevents unneeded hospital visits.Recent trending data shows no anomalies in reported failures from the field.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 mdr report #: mw5170433, it was reported that,"on (b)(6) 2025, the internal balloon in our daughter's g tube (gastrostomy tube) failed causing it to be dislodged.This required us to insert a foley catheter and travel to the emergency room at (b)(6) to have a new g tube inserted and a fluoroscopy to confirm placement.In the two weeks since she has had her g tube, this is the second time it has fallen out due to a manufacturing defect causing the internal balloon to fail.The first time was on (b)(6) 2025 while she was still inpatient in the newborn critical care center.On that time, she had to wait 10 hours between feeds due to the wait to get the fluoroscopy study done to confirm placement before she could be fed again.As a young infant, it was very distressing for her to miss multiple scheduled feeds due to this manufacturing error.We were told by the pediatric surgery team at (b)(6) that they checked the balloon and there was a small leak which caused it to fail.They said they have contacted the manufacturer in the past and were told that sometimes the lining of the balloon is shaved down too far causing it to fail prematurely.This is an unacceptable level of manufacturing error which has caused distress and danger to our infant on multiple occasions.The product is called a minione balloon button low profile gastrostomy feeding tube.The size is 12f x 1.0 cm.It is manufactured by applied medical technology; inc.We also had to pay a $(b)(6) emergency room co-pay due to this defect".

• Brand Name: MINI ONE BALLOON BUTTON
• Common Device Name: LOW PROFILE GASTROSTOMY 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: 22204499
• Report Number: 1526012-2025-00008
• Device Sequence Number: 17831591
• Product Code: KNT
• UDI-Device Identifier: 00842071113827
• UDI-Public: 00842071113827
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2025

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: Lay User/Patient
• Device Model Number: M1-5-1210-I
• Device Catalogue Number: M1-5-1210-I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 06/13/2025
• 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 Age: 2 MO
• Patient Sex: Female
• Patient Weight: 3 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native, White