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

Model Number	SM1-5-1255
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Rn administered medication and sterile water flush through gtube mic-key extension without a problem.Rn turned to get feeding syringe and when she turned back toward the patient saw that the whole gtube button and extension was out of the patient on the bed.The balloon button appeared to be completely deflated.Rn immediately put a red rubber catheter in the hole to maintain patency.A replacement balloon button was inserted easily into place.An abdominal xray was done to confirm placement prior to feeds being resumed.2 rns were present and examined the old balloon button.The balloon did not appear to be holding the correct shape/was easily disformed.

• 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: 13497180
• Report Number: 13497180
• Device Sequence Number: 19840016
• Product Code: KNT
• UDI-Device Identifier: 00842071119904
• UDI-Public: 00842071119904
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2022
• Report Date (Section F): 02/02/2022

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: Health Professional
• Device Model Number: SM1-5-1255
• Device Catalogue Number: SM1-5-1255
• Device Lot Number: 210909-252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/09/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/02/2022