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	05/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Patient gastric tube (gt) was noted out and laying in bed after working with pt during first care.Pt was vocal about a previous history of the gt becoming dislodged during multiple/different times and stated would be extra careful of this during therapy.Also stated in report gt became dislodged multiple times over 2-week period.Balloon on gt looked malfunctioned.No bleeding.Gt called gt mini one balloon button low profile feeding device.12 french 0.8 cm lot number 180920-366.Expiration 07/01/2021.Surgical fellow notified immediately by phone and came to reinsert a brand-new gt.I explained what happened and that surgical fellow came to bedside and up sized her gt to a 12 french 1.2 cm gt without incident.No bleeding to site.Resident teammate notified and expressed she would relay info to nurse practitioner.Discussed with orange team incident of gt becoming dislodged during rounds in front of surgical fellow.Manufacturer response for button g tube feeding device, mini one® balloon button (per site reporter).Manufacturer has been very helpful and is arranging for return and evaluation of all available devices.

• 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: 10074348
• Report Number: 10074348
• Device Sequence Number: 19558178
• 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: 180920366
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 4
• Date Report Sent to FDA: 05/08/2020