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

Model Number GJ-1412-22

Device Problems Detachment of Device or Device Component (2907); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 09/28/2020

Event Type  malfunction  

Event Description

Amt g-j tube placed in march malfunctioned.The ring where the j-tube fits into the port fell out and will not allow feeding set to be attached to port.Replaced this tube 6 months later.

• 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: 10755138
• MDR Text Key: 213667773
• Report Number: 10755138
• 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: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: GJ-1412-22
• Device Catalogue Number: GJ-1412-22
• Device Lot Number: 200224-006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2020
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 540 DA
• Patient Weight: 11