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

Model Number	M1-5-1210
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Per the original reporter in uf #: (b)(4), it was reported that "during nursing care, the infant's g-tube button fell out.Rn (registered nurse) noted the balloon was deflated.Surgery np (nurse practitioner) assessed g-tube noting a small hole in the balloon.Balloon remains deflated securing g-tube in place.".
Additional Manufacturer Narrative
This report is a response to mdr report # (b)(4) which was received by amt from the fda on (b)(6) 2024.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 reached out to the reporter to gather additional information regarding the complaint and to confirm that the device is not available for return.Since the device was not available for return, a visual and functional evaluation could not be performed, and device failure could not be confirmed.Based on the provided information, the reported complaint is not believed to have been caused by a manufacturing defect.A complaint has been logged in our system to track this record in complaint #: (b)(4) and will be used for trend analysis.

• Brand Name: MINI ONE
• Common Device Name: LOW-PROFILE BALLOON GASTROSTOMY 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: joshua meinke ; 8006 katherine boulevard; brecksville, OH 44141 ; 4407174000
• MDR Report Key: 18743352
• Report Number: 1526012-2024-00002
• Device Sequence Number: 7229614
• Product Code: KNT
• UDI-Device Identifier: 00842071100018
• UDI-Public: 00842071100018
• 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
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/20/2024

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
• Device Model Number: M1-5-1210
• Device Catalogue Number: M1-5-1210
• Device Lot Number: UNKNOWN
• 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: 01/22/2024
• Initial Report FDA Received Date: 02/20/2024
• 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: 3 MO
• Patient Sex: Unknown