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

Model Number M1-5-1208

Device Problems Inflation Problem (1310); Device Fell (4014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/18/2020

Event Type  malfunction  

Event 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
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine blvd; brecksville OH 44141
• MDR Report Key: 10069675
• MDR Text Key: 191411196
• Report Number: 10069675
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00842071100001
• UDI-Public: 00842071100001
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/08/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 DA
• Patient Weight: 3