MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. AMT BALLOON G-TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 7-1410

Device Problems Crack (1135); Detachment of Device or Device Component (2907); Positioning Problem (3009)

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

Event Date 09/23/2022

Event Type  malfunction  

Event Description

Amt's balloon g-tube will not securely hold tubing for feeding in either port.When tubing connected to either port, it quickly slides out.Tubing is needing to be "taped" in place while feeding is going so that patient receives his feeding.Health care provider checked in with nurse, mom and patient today.The problem seems to be at the connection point between the enteral end of the g-tube and the christmas-tree-like connector of the tubing.There is a crack, which is preventing a tight seal.Clinical staff are using tape and a posey to create a seal for the next three weeks, when the g-tube will be healed enough to be able to change it out.Surgery and neonatology are aware of this plan and approve.Health care provider have placed a note at the bedside to save this tube for our products department for evaluation following removal.

• Brand Name: AMT BALLOON G-TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine blvd; brecksville OH 44141
• MDR Report Key: 15698351
• MDR Text Key: 302685138
• Report Number: 15698351
• 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: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 7-1410
• Device Catalogue Number: 7-1410
• Device Lot Number: 220412-285
• 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: 10/03/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 90 DA
• Patient Sex: Male
• Patient Weight: 3 KG