MAUDE Adverse Event Report: HALYARD HEALTH CORTRAK* 2 NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH ELECTROMAGNETIC TRANSMIT; DH CPK NG TUBES

Model Number	40-9551
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	10/07/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
The actual device was not returned.The device history record for the reported lot number, 73111, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.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).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a halyard health product is defective or caused serious injury.The device was not returned.
Event or Problem Description
Halyard received a report stating that the corflo nasogastric tube ended up in the patient's lungs during insertion.Additional information received (b)(6) 2017 stated the patient died.No cause of death was provided.Additional information has been requested but not yet received.No additional information was provided.
Additional Manufacturer Narrative
Additional information: describe event or problem.All information reasonably known as of 20-dec-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
Additional information received 27-nov-2017 stated a cortrak unit was not used for placement.The lung placement was not verified by x-ray and the lung placement was not alone the cause of the patient's death.Additional information received 29-nov-2017 stated the nurse communicated that the cause of the patients death wasn`t this incident alone.The patient died some days after the incident, and not because of this incident.Additional information received 07-dec-2017 stated the patient's death was attributed to multi-organ failure, possible due to sepsis.There was a possible complication due to pneumonia/respiratory failure.
Additional Manufacturer Narrative
All information reasonably known as of 01-oct-2018 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).

• Common Device Name: DH CPK NG TUBES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7054236
• Report Number: 3009124963-2017-00054
• Device Sequence Number: 16446712
• Product Code: KNT
• UDI-Device Identifier: 20815149020451
• UDI-Public: 20815149020451
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K821906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2018

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: Other Health Care Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 40-9551
• Device Catalogue Number: 104605200
• Device Lot Number: 73111
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 11/27/2017; 09/04/2018
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 12/21/2017; 10/01/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death