MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORTRAK ENTERAL ACCESS SYSTEM; DH CORTRAK (EAS)

Model Number 20-0950

Device Problem Malposition of Device (2616)

Patient Problems Pain (1994); Pneumothorax (2012); Foreign Body In Patient (2687)

Event Date 01/28/2020

Event Type  Injury  

Manufacturer Narrative

The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is in-progress.All information reasonably known as of 18 feb 2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.Avanos medical inc.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 avanos medical inc.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 an avanos medical inc.Product is defective or caused serious injury.

Event Description

It was reported that a patient "had a tube placed in the lung.There was an issue reading the xray and patient was fed for 2 hours.Tf [tube feeding] stopped after patient had pain.Patient had ct [computed tomography] scan and was bronched and is stable." tube was placed by unit based educator and patient did have some coughing during placement."he did not de sat [desaturate] or have any issue with tube passing.Patient was up high in the bed and magnet in good position." the user facility stated they "saw the tube pass." additional information received 07-feb-2020 indicated that the placement was to the left lung on a male patient with a history of severe kyphosis.Additional information has been requested but not yet received.

Manufacturer Narrative

The product involved in the report has been returned and is being processed for evaluation.The investigation remains in process.All information reasonably known as of 17 apr 2020 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 avanos medical inc.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 avanos medical inc.Avanos medical inc.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 avanos medical inc.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 an avanos medical inc.Product is defective or caused serious injury.

Event Description

Additional information received 27-feb-2020 indicated "duotube placed (b)(6) 2020 at 1700.Placed using cortrak.Marking at nose 123cm.Went in with no resistance or complications.Left lung [placement].2 x-rays were completed the night of duotube placement.One being at 1720, the other at 1927.Neither mention feeding tube placement.X-ray completed on (b)(6) 2020 at 1145, post feeding tube removal, no evidence of pneumothorax.(b)(6) 2020 at 0930 ct [computed tomography] of abdomen performed.Test that found placement of duotube in the lung.Stated duotube resides in left pleural space.[bronchoscopy performed] (b)(6) 2020 at 1130." current patient status was "discharged to snf [skilled nursing facility]." additional information has been requested but not yet received.

Manufacturer Narrative

Additional information provided in b5 and b6.The investigation remains in progress.All information reasonably known as of 11 mar 2020 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 avanos medical inc.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 avanos medical inc.Avanos medical inc.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 avanos medical inc.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 an avanos medical inc.Product is defective or caused serious injury.

Manufacturer Narrative

The device history record for unit 1210017 was reviewed and the product was produced according to product specifications.The actual complaint product was returned for evaluation.Tracings from the procedure were reviewed.The tracing begins offset to the left of the midline.There is a deviation to the left at 0:19, which is not the expected pathway for gastric placement of the ng tube.The tracing in the lateral view is not consistent with expected position of a gastric placement.Visual inspection of the unit noted stress crack lines on the monitor unit.Power up was normal, both usb ports were operating correctly, and the power supply adapter was working as expected.System passed placement test.The root cause was determined to be inappropriate use.All information reasonably known as of 15 jun 2020 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 avanos medical inc.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 avanos medical inc.Avanos medical inc.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 avanos medical inc.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 an avanos medical inc.Product is defective or caused serious injury.

Manufacturer Narrative

Additional information provided in b5, b6, and e4.The investigation remains in progress.All information reasonably known as of 19 mar 2020 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 avanos medical inc.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 avanos medical inc.Avanos medical inc.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 avanos medical inc.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 an avanos medical inc.Product is defective or caused serious injury.- attachment: [mw5092923.Pdf].

Event Description

Additional information received (b)(6) 2020: fda medwatch/fda user facility report #mw5092923 received (b)(6) 2020, and the following information was provided: the product should clearly state contraindications for insertion.Additional information received (b)(6) 2020 indicated the patient was transferred to another upmc facility."last update was chest tubes were removed.He has a trach now which was a planned procedure prior to feeding tube event." "patient had a bedside bronchoscopy and chest tube placement.Also had a vats [video-assisted thoracoscopic surgery] procedure at another hospital." the tube that was removed was not saved.The tube was being used with a cortrak2 monitor.

Manufacturer Narrative

All information reasonably known as of 20 may 2024 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 avanos medical inc.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 avanos medical inc.Avanos medical inc.Has no independent knowledge of the reported event but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the avanos medical 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 an avanos medical inc.Product is defective or caused serious injury.

• Brand Name: CORTRAK ENTERAL ACCESS SYSTEM
• Type of Device: DH CORTRAK (EAS)
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): CORPAK MEDSYSTEMS, INC. A DIVISION OF HALYARD HLTH; 1001 asbury dr.; buffalo grove IL 60089
• Manufacturer Contact: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 9726546
• MDR Text Key: 185262940
• Report Number: 3011270181-2020-00029
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10680651472011
• UDI-Public: 10680651472011
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113351
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/20/2024

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
• Device Operator: Health Professional
• Device Model Number: 20-0950
• Device Catalogue Number: 104720102
• Device Lot Number: 1210017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/19/2020
• Supplement Dates Manufacturer Received: 02/27/2020; 02/25/2020; 03/26/2020; 06/08/2020; 04/26/2024
• Supplement Dates FDA Received: 03/13/2020; 03/19/2020; 04/20/2020; 06/16/2020; 05/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male