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

Model Number	M1-5-1412
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is a response to uf report # (b)(4) which was received by amt from the fda on 10/26/2020.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.We have reached out to the customer in attempts to retrieve the device for examination and additional information regarding the report.The return process is in progress with device expected to be received in the near future.Since the device was not returned yet, a visual and functional evaluation could not be performed and device failure cannot be confirmed at this time.A device history review was run on the provided lot number with no anomalies found and no other complaints from other reporters.Based on the provided information, the reported problem is not believed to have been caused by a manufacturing defect.Complaint # 20201193 was assigned to this report.
Event or Problem Description
Per original report #: (b)(4), "describe the event or problem: g-tube leaking, removed and flushed balloon noted to be leaking.What problem did the user have (check all that apply): device failed (e.G.Broke, couldn't get it to work or stopped working).".

• 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: 10900187
• Report Number: 1526012-2020-00018
• Device Sequence Number: 2539153
• Product Code: KNT
• UDI-Device Identifier: 00842071100148
• UDI-Public: (01)00842071100148(17)230501(10)200526-034
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/24/2020

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: No Information
• Device Expiration Date: 05/01/2023
• Device Model Number: M1-5-1412
• Device Catalogue Number: M1-5-1412
• Device Lot Number: 200526-034
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1