MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. G-JET® TRANSGASTRIC-JEJUNAL FEEDING DEVICE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number GJ-1430-45-I

Device Problems Deflation Problem (1149); Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 06/22/2022

Event Type  malfunction  

Event Description

Gastrojejunostomy (gj) tube appeared to be partially dislodged.Pediatric surgery consulted to evaluate.On examination, the tube was freely mobile in the abdominal wall and advanced back into the abdomen without difficult.The balloon appeared to be down or ruptured given the laxity and free movement of the tube at the abdominal wall.Attempts to deflate the balloon were unsuccessful with no fluid pulled back even after infusing sterile water into the balloon and is concerning for balloon rupture.Patient went to the operating room for replacement of malfunctioning gj tube under general anesthesia.

• Brand Name: G-JET® TRANSGASTRIC-JEJUNAL FEEDING DEVICE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine blvd; brecksville OH 44141
• MDR Report Key: 16408131
• MDR Text Key: 309876235
• Report Number: 16408131
• 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: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: GJ-1430-45-I
• Device Catalogue Number: GJ-1430-45-I
• 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: 02/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 4745 DA
• Patient Sex: Male