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

Model Number M1-5-1208-I

Patient Problem Insufficient Information (4580)

Event Date 09/21/2023

Event Type  malfunction  

Event Description

Upon checking placement of gastrostomy feeding tube, milk leakage was found on patient's clothing & blanket.Balloon was checked and found to be ruptured.

• 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: 17994534
• MDR Text Key: 326387087
• Report Number: 17994534
• 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: 10/11/2023,10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: M1-5-1208-I
• Device Catalogue Number: M1-5-1208-I
• Device Lot Number: 221103-112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/11/2023
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2023
• 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
• Patient Weight: 5 KG
• Patient Ethnicity: Hispanic