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

Model Number	20-0950
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The actual complaint product was not returned for evaluation.A review of the device history record is not possible as it is unknown which lot is associated with the event.All information reasonably known as of 12-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.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).Device not returned.
Event or Problem Description
It was reported that a placement of a feeding tube was performed utilizing the system, with the smart receiver unit positioned on the chest and secured with tape.The initial insertion was uneventful.However, post procedure, and x-ray discovered the feeding tube to be located in the left lung.The tube was immediately removed and replaced per orders.The patient did not experience any pneumothorax upon replacement.There was no reported patient injury.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.Upon completion of the sample evaluation and investigation; a follow-up report will be filed.All information reasonably known as of 29-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.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.No physical damage was noted to the monitor unit and receiver unit.The returned system was evaluated and tested with controlled stylet and interconnect cable returned with the system.The stylet used when the failure mode was observed was not returned for evaluation.System was evaluated and all tested results were within specifications.Root cause could not be identified.The reported complaint was not confirmed.All information reasonably known as of 14-aug-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: 6644321
• Report Number: 3009124963-2017-00029
• Device Sequence Number: 16470210
• Product Code: KNT
• UDI-Device Identifier: 10815149024698
• UDI-Public: 10815149024698
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 20-0950
• Device Catalogue Number: 104564100
• Device Lot Number: 1308017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Initial Date Received by Manufacturer: 05/19/2017
• Supplement Date Received by Manufacturer: 06/15/2017; 07/26/2017
• Initial Report FDA Received Date: 06/15/2017
• Supplement Report FDA Received Date: 06/30/2017; 08/17/2017
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 69