MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORTRAK2 NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH ETS; DH CORTRAK DISPOSABLES

Model Number	20-9551TRAK2
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Unspecified Respiratory Problem (4464)
Date of Event	10/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reported, the cortrak tube had been in place for 15 days on (b)(6) 2022 and the patient was scheduled nothing by mouth (npo) for the operating room.When tube feeding was restarted, that afternoon, the patient reportedly experienced worsening respiratory status which prompted a chest x-ray for shortness of breath.The nurse reported that no prior issues were noted when flushing the tube; however at some point the tube became retracted from the d2 area where it coiled in the patient¿s stomach.The radiologist report read as attached.Per the clinician, upon removal of the tube, it was found to be in two pieces; the proximal end of the tube was removed, the distal end remained in the patient's stomach.It was reported, the patient will be reintubated after the endoscopic removal of the broken tube.The patient¿s current condition was not reported.Additional information received on (b)(6) 2022 reported, the tube was originally placed on (b)(6) 2022 at 9:00; the patient experienced respiratory distress at 8:30pm on (b)(6) 2022.A chest x-ray was completed and the physician notified the registered nurse (rn) that the tube was either kinked or perforated; the rn pulled the tube 9:20.The radiologist report confirmed the distal portion of the tube remained inside the patient; treatment was delayed.The patient was scheduled 24 hrs later with the gastroenterologist (gi) to remove the remaining distal fragment; the patient had to be transported for removal of the distal fragment.The patient¿s current condition was not reported.
Additional 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 (b)(6) 2022 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 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.
Additional Manufacturer Narrative
The device history record for lot 30193613 was reviewed and the product was produced according to product specifications.The actual complaint product was not returned for evaluation; therefore, the root cause could not be determined.All information reasonably known as of 16 dec 2022 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 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: CORTRAK2 NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH ETS
• Common Device Name: DH CORTRAK DISPOSABLES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V. (AVENT 1); circuito industial no.40; colonia obrera; nogales, cp
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 15848845
• Report Number: 9611594-2022-00141
• Device Sequence Number: 5216367
• Product Code: KNT
• UDI-Device Identifier: 00350770458182
• UDI-Public: 00350770458182
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K821906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/24/2024
• Device Model Number: 20-9551TRAK2
• Device Lot Number: 30193613
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown