MAUDE Adverse Event Report: HALYARD HEALTH CORTRAK 2 ENTERAL ACCESS SYSTEM; DH CORTRAK (EAS)

Model Number	P20-0950
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Pneumothorax (2012)
Date of Event	05/05/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 07-jun-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
It was reported that a patient experienced a pneumothorax following a difficult nasogastric tube (ngt) placement.Within 10 minutes of the placement, an x-ray confirmed that the ngt was not in the gastric region.The ngt was immediately withdrawn and a chest tube was inserted.It was noted that the patient was admitted with a brain stem injury and expired eight days later.Additional information received on 19-may-2017 stated that a clinician placed the tube with the assistance of the cotrak enteral access system.An x-ray confirmation was taken to verify the location of the placement.The x-ray revealed that the tube extended into the left mainstem with no obvious pneumothorax at the time.The pneumothorax developed after removal when the chest tube was placed.
Additional Manufacturer Narrative
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).
Additional Manufacturer Narrative
The device history record for the reported lot number, 1211005, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.All information reasonably known as of 27-sep-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).

• Brand Name: CORTRAK 2 ENTERAL ACCESS SYSTEM
• Common Device Name: DH CORTRAK (EAS)
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6630138
• Report Number: 3009124963-2017-00025
• Device Sequence Number: 16414595
• Product Code: KNT
• UDI-Device Identifier: 10815149024698
• UDI-Public: 10815149024698
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K113351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: P20-0950
• Device Catalogue Number: 104655800
• Device Lot Number: 1211005
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/17/2017
• Supplement Date Received by Manufacturer: Not provided; 09/21/2017
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 06/29/2017; 10/10/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Other
• Patient Age: 61 YR
• Patient Weight: 74