MAUDE Adverse Event Report: CORPAK MEDSYSTEMS, INC. CORTRAK 2 EAS ELECTROMAGNETIC TRANSMITTING STYLET AND CORFLO FEEDING TUBE; TUBE, FEEDING

Model Number	20-9551TRAK2A
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Upon preparing a cortrak 2 feeding tube for insertion, the rn noticed the guide-wire protruding into the exit opening of the tube.The tube was removed from service.His safety concern is that the guide-wire could potentially harm a patient if inserted.The guide-wire tips are typically a couple of centimeters proximal to the tip of the tube.The rn directly involved in this event contacted the corpak medsystems/halyard sales rep immediately, and she stated she would contact her quality service department and will make arrangements to replace our stock of tubes.Upon inspection of the remaining unopened tubes it appears there are other tubes with similar issues.

• Brand Name: CORTRAK 2 EAS ELECTROMAGNETIC TRANSMITTING STYLET AND CORFLO FEEDING TUBE
• Common Device Name: TUBE, FEEDING
• Manufacturer (Section D): CORPAK MEDSYSTEMS, INC.; 1001 asbury dr.; buffalo grove IL 60089
• MDR Report Key: 6960968
• Report Number: 6960968
• Device Sequence Number: 1364793
• Product Code: KNT
• UDI-Device Identifier: 10815149023608
• UDI-Public: (01)10815149023608
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/12/2017
• Report Date (Section F): 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 20-9551TRAK2A
• Device Catalogue Number: 20-9551TRAK2A
• Device Lot Number: 79092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/19/2017
• 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: 10/12/2017