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

Model Number	M1-5-1212
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is a response to report # (b)(4) which was received by amt from the fda on 03/22/2021.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 worked with the reporter and obtained the device for examination on 3/24/2021.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 anomalies 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 the initial reporter's original report in report #: (b)(4), "g tube dislodged/removed.Infant was transferred with a gastrostomy tube (gt).Balloon was found to have a leak.10fr suction tube used to maintain patency.Balloon on device failed.On inspection device balloon will not inflate a small amount but beyond 0.5ml of air everything just leaks out.This device was placed by an outside facility so no lot number information is available.Manufacturer has been contacted by email.There was no detectable harm.".

• 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: 11697365
• Report Number: 1526012-2021-00013
• Device Sequence Number: 4434072
• Product Code: KNT
• UDI-Device Identifier: 00842071100025
• UDI-Public: (01)00842071100025(17)220301(10)190416-144
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 04/20/2021

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: No Information
• Device Expiration Date: 03/01/2022
• Device Model Number: M1-5-1212
• Device Catalogue Number: M1-5-1212
• Device Lot Number: 190416-144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 6 MO