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

Model Number GJ-1417-22

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2020

Event Type  malfunction  

Manufacturer Narrative

This report is a response to uf report # (b)(4) which was received by amt from the fda on 05/04/2020.Based on the provided information, the complaint is not a reportable event per 21 cfr section 803.There was no death.There was no serious injury, as defined by the fda.This was not life-threatening, nor did this result in permanent impairment or necessitate medical or surgical intervention to preclude permanent impairment.Amt has reached out to the customer several times via email and phone in attempts to retrieve the device for examination.The customer has not provided a device for examination at this time.Since the device has not been returned a visual and functional evaluation could not be done and device failure could not be confirmed.A device history review was performed with the reported lot information with no anomalies detected in the record.Based on the provided information the reported problem is not believed to have been caused by a manufacturing defect.Complaint # (b)(4) was assigned to this report.We will provide additional information to the fda if the device or additional information is able to be obtained and its analysis changes the conclusion of this report.

Event Description

Per medwatch report #: (b)(4): "applied medical technologies g-jey button, 14f, 1.7cm, 22cm tube placed in the fall, ref #gj-1417-22, lot#190808-017, exp.07/01/2022.Plastic ring where feeding set connects fell out preventing parent from being able to connect feeding set.Tube emergently had to be replaced.This has happened with this type of tube in the past.Procedure: small intestinal endoscopy with conversion of percutaneous gastrostomy tube to percutaneous jejunostomy tube.3 months later: preop dx: jejunostomy tube malfunction.Procedure performed: small intestinal endoscopy with conversion of percutaneous gastrostomy tube to percutaneous jejunostomy tube procedure detail: the defective amt 1.2 cm 14-french 22cm tube was removed and the guide wire was pass into stomach and grap by non need graspers and dragged to the pylorus and second protion duodenum.".

• Brand Name: G-JET(R) TRANSGASTRIC-JEJUNAL FEEDING DEVICE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville, oh
• Manufacturer (Section G): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville, oh
• Manufacturer Contact: joshua meinke ; 8006 katherine boulevard; brecksville, oh ; 7174000252
• MDR Report Key: 10112859
• MDR Text Key: 210636068
• Report Number: 1526012-2020-00007
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/02/2020

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 Operator: Health Professional
• Device Expiration Date: 07/01/2022
• Device Model Number: GJ-1417-22
• Device Catalogue Number: GJ-1417-22
• Device Lot Number: 190808-107
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2020
• Initial Date FDA Received: 06/02/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/08/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 12 MO
• Patient Weight: 8