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

Model Number M1-5-1215

Device Problems Device Dislodged or Dislocated (2923); Unintended Deflation (4061)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2023

Event Type  malfunction  

Event Description

G-tube was found to be dislodged from infant's abdomen.Upon inspecting the mini button, the balloon was deflated.Tried to reinflate the balloon with sterile water and the balloon wouldn't hold water.

• 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: 16617859
• MDR Text Key: 312051543
• Report Number: 16617859
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00842071100032
• UDI-Public: (01)00842071100032
• 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: 02/21/2023

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 Model Number: M1-5-1215
• Device Catalogue Number: M1-5-1215
• Device Lot Number: 220104-052
• 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: 02/21/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/27/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1