MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. MINI ONE BALLOON BUTTON; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	M1-5-1215
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is a response to uf report # (b)(4) which was reported to amt by fda on 06/28/2021.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 and retrieved the failed device for analysis.The device was analyzed and the reported failure was confirmed.A device history review was performed for the lot with no anomalies detected in the record.Based on the provided information, the reported problem did not occur due to a manufacturing defect, but due to a combination of excessive stress and patient/environment usage conditions.Complaint # (b)(4) was assigned to this report.We will provide additional information to the fda if future information or analysis changes the conclusion of this report.
Event or Problem Description
Per the original report in uf report #: (b)(4): "opening comes apart when opening clamp up to place extension g-tube in place.Looks like is has cracked apart and leaking with feeds around.".

• Brand Name: MINI ONE BALLOON BUTTON
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville OH 44141
• MDR Report Key: 12235161
• Report Number: 1526012-2021-00016
• Device Sequence Number: 3532453
• Product Code: KNT
• UDI-Device Identifier: 00842071100032
• UDI-Public: (01)00842071100032(17)230601(10)200721-265
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K161413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• 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): 07/27/2021

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 Expiration Date: 06/01/2023
• Device Model Number: M1-5-1215
• Device Catalogue Number: M1-5-1215
• Device Lot Number: 200721-265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1