MAUDE Adverse Event Report: HALYARD HEALTH CORTRAK 2 NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH ELECTROMAGNETIC TRANSMIT; DH CORTRAK DISPOSABLES

Model Number	20-9368TRAK2
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).There is no information provided regarding the return of the actual complaint product to the manufacturer.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 20-oct-2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a halyard health product is defective or caused serious injury.Device not returned.
Event or Problem Description
It was reported via fda maude report key (b)(4): "elderly female admitted to burn unit for 23% total body surface area (tbsa) burn.Cortrak placed about three weeks later and removed about a month after insertion when it was noted that the patient had tube feeds coming out of her mouth when medications were administered through the adjacent ng tube.The cortrak broke off at the 20 cm mark.The existing tip of the tube appears to be ruptured.Approximately 20 cm of the end of the cortrak was retained in the stomach.It was successfully removed on the same day via bedside egd.".

• Brand Name: CORTRAK 2 NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH ELECTROMAGNETIC TRANSMIT
• Common Device Name: DH CORTRAK DISPOSABLES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6965536
• Report Number: 3009124963-2017-00050
• Device Sequence Number: 634027
• Product Code: KNT
• UDI-Device Identifier: 10815149023882
• UDI-Public: 10815149023882
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K821906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/22/2017

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: Other
• Device Model Number: 20-9368TRAK2
• Device Catalogue Number: 104579100
• Device Lot Number: ANP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2017
• Initial Report FDA Received Date: 10/20/2017
• Patient Sequence Number: 1