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

Model Number	20-9431TRAK2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	01/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint product was not returned for evaluation.The device history record for the reported lot number was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.Lung placement is a known risk of any nasogastric tube placement procedure.Per communication with the customer, tubes were not being used with a cortrak device but were being placed blindly.No defects were reported with the cortrak system or disposables.All information reasonably known as of 11-may-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.Halyard health 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).
Event or Problem Description
A medwatch report was received on via medwatch # mw5068628.The report stated,"nurse was following orders to place oro-gastric feeding tube.After placement of tube, the placement was being confirmed with x-ray which showed feeding tube not in stomach, ft was withdrawn and re-attempted.Approximately 30 minutes later it was clinically apparent that the patient had a pneumothorax requiring placement of chest tube." additional information received stated that adequate training was not provided and the issue could be due to user error.Additional information received on 04-may-2017 from the hospital's risk management representative stated that an x-ray confirmed the tube was not in the stomach.The nasogastric (ng) tube was replaced and confirmed in to be in the stomach.Upon follow-up, the patient developed pneumothorax.It was noted that the hospital was not using the ng tubes properly.The ng tube was used without the use of the cortrak device/tracking.The device was used by nurse that did not have appropriate training.

• 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: 6562915
• Report Number: 3009124963-2017-00021
• Device Sequence Number: 18865540
• Product Code: KNT
• UDI-Device Identifier: 20815149023940
• UDI-Public: 20815149023940
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/17/2017

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: Nurse
• Device Expiration Date: 01/31/2022
• Device Model Number: 20-9431TRAK2
• Device Catalogue Number: 104579700
• Device Lot Number: 77082
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2017
• Initial Report FDA Received Date: 05/12/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other