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

Model Number	M1-5-1408
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is a response to report # 0733000000-2020-8034 which was received by amt from the fda on 09/28/2020.Based on the provided information, the incident 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 has reached out to the customer in attempts to retrieve the device for examination and additional information regarding the report and the device was received for examination.The device was examined and there was no indication that a manufacturing defect caused the failure of the device.A device history review was performed and no anabolies were found for the related lot.Complaint # (b)(4) was assigned to this report.The complaint has been logged and will be used in our complaint trending process for future product enhancements.
Event or Problem Description
Per for the reporter's description of the complaint in original report #: (b)(4), "describe the event or problem: patient found with g-tube out of tract and balloon laying on bed, bedside nurse tried to re-inflate balloon and unable to do so.Water was coming out of the balloon as it was instilled.What problem did the user have (check all that apply): device failed".

• Brand Name: MINI ONE(R) 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: 10743833
• Report Number: 1526012-2020-00016
• Device Sequence Number: 3334483
• Product Code: KNT
• UDI-Device Identifier: 00842071100131
• UDI-Public: 01008420711001311722100110191118035
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 10/01/2022
• Device Model Number: M1-5-1408
• Device Catalogue Number: M1-5-1408
• Device Lot Number: 191118-035
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1