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

Model Number	M1-5-1412-I
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Per the original reporter in uf #:(b)(4), it was reported that the, "registered nurse (rn) noted that minione balloon button gastronomy tube (gt) lifting slightly to one side.Tubing taped to prevent any tugging.Site flushed, no leaking noted at gt stoma site.Medications administered at [time redacted].Rn flushed and noted no leaking at stoma site.Pulled back from balloon inflation port and noted 1ml gastric content.Gt balloon port inflated and unable to pull back post inflation.".
Additional Manufacturer Narrative
This report is a response to medsun report # (b)(4) which was received by amt from the fda on 02/18/2025.The occurrence was originally reported to amt on 02/03/2025 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 the balloon had failed.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).

• Brand Name: MINIONE 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: 21621385
• Report Number: 1526012-2025-00003
• Device Sequence Number: 18271648
• Product Code: KNT
• UDI-Device Identifier: 00842071113957
• UDI-Public: 00842071113957
• 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): 03/17/2025

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: M1-5-1412-I
• Device Catalogue Number: M1-5-1412-I
• Device Lot Number: 240822-252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 8 MO
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White