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	02/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Method: the complaint product was not returned for evaluation.A review of the device history record is in-progress.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 (b)(6) 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.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).Device not returned.
Event or Problem Description
A medwatch report was received via medwatch # mw5068629.The report stated: "nurslng received order to place oro-gastric feeding tube.Post placement, ft confirmed by chest x-ray to be in stomach.Short time thereafter, pt began to go into respiratory failure and was found to have pneumothorax requiring placement of chest tube." additional information received on (b)(6) 2017 from the hospital's risk management representative stated that an x-ray confirmed the tube was in the patient's stomach, and later developed pneumothorax.It was noted that the hospital was not using the nasogastric (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.
Additional Manufacturer Narrative
The manufacturer narrative of the initial report contained "a review of the device history record is in-progress." however, the dhr results were also provided.Therefore, this statement was included in error and should be excluded.All information reasonably known as of (b)(6) 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.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).
Event or Problem Description
"nursing received order to place oro-gastric feeding tube.Post placement, ft confirmed by chest x-ray to be in stomach.Short time thereafter, pt began to go into respiratory failure and was found to have pneumothorax requiring placement of chest tube.".

• 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: 6561689
• Report Number: 3009124963-2017-00020
• Device Sequence Number: 10963245
• 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,Followup
• Report Date (Section B): 06/27/2017

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): FDA Requested
• Initial Date Received by Manufacturer: 04/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2017
• Supplement Report FDA Received Date: 06/28/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other