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

Model Number	M1-5-1208
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Patient's 12fr amt g-tube fell out during hands on care.Balloon on g-tube that fell out was deflated.Balloon was tested after it fell out and was leaking.Manufacturer response for low profile feeding device, mini one balloon button (per site reporter) manufacturer is sending label for return to conduct an investigation.

• Brand Name: MINI ONE® BALLOON BUTTON
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine blvd; brecksville OH 44141
• MDR Report Key: 10069675
• Report Number: 10069675
• Device Sequence Number: 19002417
• Product Code: KNT
• UDI-Device Identifier: 00842071100001
• UDI-Public: 00842071100001
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2020
• Report Date (Section F): 05/08/2020

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 Model Number: M1-5-1208
• Device Catalogue Number: M1-5-1208
• Device Lot Number: 180920-366
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 DA
• Patient Weight: 3
• Date Report Sent to FDA: 05/08/2020