MAUDE Adverse Event Report: CORPAK MEDSYSTEMS, INC. CORFLO ULTRA NG FEEDING TUBE; TUBE, FEEDING

Model Number	20-7431AIV2
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
Corpak corflo enteral feeding tube guidewire and tubing kinked, unable to flush or use.Ref 20-7431aiv2, lot 79540, (b)(4).Tube removed and replaced with effective device.No harm to patient.

• Brand Name: CORFLO ULTRA NG FEEDING TUBE
• Common Device Name: TUBE, FEEDING
• Manufacturer (Section D): CORPAK MEDSYSTEMS, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7769700
• Report Number: 7769700
• Device Sequence Number: 2217813
• Product Code: FPD
• UDI-Device Identifier: 10815149023516
• UDI-Public: (01)10815149023516(17)220930(10)79540
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/03/2018
• Report Date (Section F): 08/06/2018

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: 20-7431AIV2
• Device Catalogue Number: 20-7431AIV2
• Device Lot Number: 79540
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/09/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2018
• 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: 08/06/2018