MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORTRAK ENTERAL ACCESS SYSTEM - RECEIVER UNIT; DH CORTRAK (EAS)

Model Number	20-0952
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pneumothorax (2012)
Type of Reportable Event	Serious Injury
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 not possible as no lot number was provided.All information reasonably known as of 07 aug 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 patient experienced a pneumothorax in the right lung during a nasogastric (ng) tube placement using the cor trak 2.The patient is ok but required ventilation at the time of the incident.The issue was reported to be caused by "user error." per additional information received on 7 aug 2019, the patient was not harmed, but a chest tube was placed.The patient is currently doing fine.It was again reported that the cause of the issue was "user error.".

• Brand Name: CORTRAK ENTERAL ACCESS SYSTEM - RECEIVER UNIT
• Common Device Name: DH CORTRAK (EAS)
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8887369
• Report Number: 3006646024-2019-00012
• Device Sequence Number: 227264
• Product Code: KNT
• UDI-Device Identifier: 10680651472127
• UDI-Public: 10680651472127
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 20-0952
• Device Catalogue Number: 104721100
• Device Lot Number: UNKNOWN
• 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: 07/23/2019
• Initial Report FDA Received Date: 08/13/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention