MAUDE Adverse Event Report: APPLIED MEDICAL G-J FEEDING TUBE

Model Number GJ1412-22

Device Problems Disconnection (1171); Defective Device (2588)

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

Event Date 04/13/2017

Event Type  malfunction  

Event Description

On (b)(6) 2017 during tube feedings through gj tube, the hardened disc on top of the silicone pot on the j-side disconnected and prevented the use of this port from feeding tube connection.On (b)(6) 2017 to operating room for removal of defective tube and reinsertion of new gj tube.Dates of use: (b)(6) 2017.Diagnosis or reason for use: pulmonary hypertension.Is the product compounded: no.Is the product over the counter: no.

• Brand Name: G-J FEEDING TUBE
• Type of Device: G-J FEEDING TUBE
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa rancho; santa margarita CA 92688
• MDR Report Key: 6519170
• MDR Text Key: 73729647
• Report Number: MW5069280
• Device Sequence Number: 1
• Product Code: FPD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2019
• Device Model Number: GJ1412-22
• Device Lot Number: 161205-208
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 MO
• Patient Weight: 7