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	Dyspnea (1816); Pleural Effusion (2010)
Date of Event	06/14/2017
Type of Reportable Event	Serious Injury
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 28-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 an nasogastric (ng) tube was placed into the right lung of the patient by the end-user in the intensive care unit (icu).It was noted that there was no fault with the placement system, but it was concluded that the end-user of the system placed the tube into the lung erroneously.The tracing on the printout and on the monitor showed that the tube was feeding into the lung, but the end-user did not stop.The patient experienced shortness of breath, and was given an x-ray, which showed the tube in the lung.The patient was noted to have pleural effusion, and consequently had a chest tube placed.Currently, the patient is stable in the icu with no additional ng tube placed.No further information was received.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of (b)(4) 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 system was received in used condition.The receiver unit has a crack on the top enclosure.The device was tested with known representative components (stylet, interconnect cable and anatomical model) which were already verified for sample evaluations.After performing the testing for placement following the approved instructions for use, the test results were verified to be within specifications and the monitor unit functioning as intended.The corview file related to the placement was reviewed.The placement file indicates that the receiver unit was likely not placed correctly at the xiphoid location.The tracing shows the placement starting at the left of the midline, which suggests the receiver was not in the correct location.At the 45 second mark of the same placement, the user advanced the feeding tube to the right side of the anatomy which is not indicative of a normal gi placement per the approved instructions for use.The root cause is attributed to incorrect use by the user.The tracing is not indicative of normal gi placement per the ifu.All information reasonably known as of 10-oct-2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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).

• 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: 6684112
• Report Number: 3009124963-2017-00030
• Device Sequence Number: 11255464
• Product Code: KNT
• UDI-Device Identifier: 10815149024698
• UDI-Public: 10815149024698
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2017

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: Health Professional
• Device Model Number: P20-0950
• Device Catalogue Number: 104655800
• Device Lot Number: 1211004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Initial Date Received by Manufacturer: 06/16/2017
• Supplement Date Received by Manufacturer: 07/11/2017; 09/24/2017
• Initial Report FDA Received Date: 07/03/2017
• Supplement Report FDA Received Date: 08/04/2017; 10/10/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 62