MAUDE Adverse Event Report: CORPAK MEDSYSTEMS, INC. CORFLO ULTRA NG FEEDING TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	20-7438
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Doctor placed #8fr 43" corflo enteral feeding tube in patient.Placement confirmed by x-ray.Doctor then was unable to removed stylet, and the feeding tube was removed.After removal, stylet still unable to be removed.Corflo feeding tube placed in this patient by md, cxr confirmed placement.Md unable to remove stylet from tube.Tube removed.

• Brand Name: CORFLO ULTRA NG FEEDING TUBE
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CORPAK MEDSYSTEMS, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7826256
• Report Number: 7826256
• Device Sequence Number: 16437883
• Product Code: KNT
• UDI-Device Identifier: 10815149023547
• UDI-Public: (01)10815149023547
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/25/2018
• Report Date (Section F): 07/25/2018

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
• Operator of Device: Health Professional
• Device Model Number: 20-7438
• Device Catalogue Number: 20-7438
• Device Lot Number: 79453
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/29/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/25/2018