MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORTRAK 2 NG/NI FEEDING TUBE W/ ELECTROMGNT TRNSMITTING STYLET & ENFIT CONNECTOR; DH CORTRAK DISPOSABLES

Model Number	40-9551TRAK2
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report was initially filed under 3011270181-2019-00008; however, the manufacturer reference number was incorrect.This initial report replaces the original initial report, and all further follow ups will be filed under this report #.The sample is reported to be available, but has not yet been received by the manufacturer.The device history record for lot 0203067326 was reviewed and the product was produced according to product specifications.All information reasonably known as of 06 mar 2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that the customer had difficulty removing the guidewire from the tube upon initial replacement.This led to the patient desaturating.Per additional information received 27 feb 2019, the issue with the guidewire prolonged the procedure, and this, along with the patient's underlying condition, led to desaturation.No further information was provided.

• Brand Name: CORTRAK 2 NG/NI FEEDING TUBE W/ ELECTROMGNT TRNSMITTING STYLET & ENFIT CONNECTOR
• Common Device Name: DH CORTRAK DISPOSABLES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8397604
• Report Number: 9611594-2019-00049
• Device Sequence Number: 10811286
• Product Code: KNT
• UDI-Device Identifier: 20815149020918
• UDI-Public: 20815149020918
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K821906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2019

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 Expiration Date: 09/01/2023
• Device Model Number: 40-9551TRAK2
• Device Catalogue Number: 104605300
• Device Lot Number: 0203067326
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 03/06/2019
• Patient Sequence Number: 1