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

Model Number M1-5-1410-I

Device Problems Leak/Splash (1354); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

Patient Problem Failure of Implant (1924)

Event Date 10/19/2021

Event Type  malfunction  

Event Description

The internal retention balloon of the 14fr x 1.0cm minione balloon button low profile feeding device leaked causing the gastrostomy tube to be dislodged from the patient.Patient's mother reported this as the second time this has happened, a similar situation occurred two weeks prior where the tube came out and the balloon was not intact.When trying to inflate the tube there was obvious leakage noted (lot 210715-116, expiration date 2024-06-01, ref #(b)(4).

• 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: 12915164
• MDR Text Key: 281595996
• Report Number: 12915164
• Device Sequence Number: 1
• Product Code: KNT
• 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: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: M1-5-1410-I
• Device Catalogue Number: M1-5-1410-I
• Device Lot Number: 210715-116
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 150 DA
• Patient Sex: Male