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
The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is in-progress.All information reasonably known as of 05 mar 2019 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 avanos medical inc.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 avanos medical inc.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.(b)(4).Device not returned.
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.
Additional Manufacturer Narrative
Per review, it was determined that the initial report under 3011270181-2019-00008 was filed under the incorrect manufacturer reference number, and a new initial report was filed under a new number of (b)(4).All further updates to the report will occur under the number (b)(4).No further updates will be submitted under the report number 3011270181-2019-00008.All information reasonably known as of (b)(6) 2019 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 avanos medical inc.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 avanos medical inc.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).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 an avanos medical inc.Product is defective or caused serious injury.

• 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: 8394276
• Report Number: 3011270181-2019-00008
• Device Sequence Number: 16465831
• 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,Followup
• Report Date (Section B): 03/06/2019

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 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
• Initial Date Received by Manufacturer: 02/22/2019
• Supplement Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 03/08/2019
• Patient Sequence Number: 1