MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORTRAK 2 NG/NI FEEDING TUBE W/ ELECTROMAGNETIC TRANSMITTING STYLET; DH CORTRAK DISPOSABLES

Model Number	40-9431TRAK2
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Cough (4457)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record is not possible as no lot number was provided; therefore, the udi-pi is unavailable.The product involved in the report has been returned and the investigation remains in progress at this time.All information reasonably known as of 27 may 2025 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.
Event or Problem Description
It was reported, ¿we had a cortrak break in half in a patient this morning.The nurse noticed that the patient was gagging more.When she looked into the back of her throat, she noted that the nasogastric [ng] tube was split (still attached at time).The team was able to safely remove both halves of the ngt.According to the registered nurse [rn] and provider at bedside there were no visible bite marks on the tube, but there was a single linear rip.The events leading up to this are a little unclear, and i am hoping to clarify with the rn tomorrow morning.As we looked into it, the staff started to state that they are clogging frequently.¿ there was no harm to the patient.
Event or Problem Description
Per additional information received on 3jun2025, the tube was in place 19 days.There was no difficulty noted during tube insertion.The patient uses the tube for continuous feeding.There are no blended feeds or thick consistency formulas.The tube is used for oral and/or crushed medication.There are no oils or oil-based medication.The patient has/had ¿episodes of severe vomiting- ngt placed- tube not flushed for several days.Generally flushed 2x/day with po med admin.¿ the tube is flushed manually and via pump programming.60cc syringes are used.Pump settings used was ¿65ml/hr tf, 25ml/hr flush.¿ clogging was noted the day before the event.The tube was documented as ¿not patent.¿ three hours later, the tube was documented as ¿now patent.¿ alkalinized enzyme was used to unclog the tube.Tylenol tablet & milk of mag given prior to tube clogging.
Additional Manufacturer Narrative
All information reasonably known as of 02 jul 2025 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.
Additional Manufacturer Narrative
H6 investigation conclusions/appropriate term/code not available: inappropriate use.The sample device was examined showing that the tubing had signs of damage and discoloration.There was a split/tear identified approximately between the 32-33 cm marking.At the 33-32cm marked location, the tubing appeared to have expanded to form a balloon shape which burst in multiple direction causing a separation of the tube into two pieces.The root cause of the reported issue seems to be a user related problem since as per the instructions for use (ifu), vigorous syringe force should not be used to irrigate, administer liquids, or unblock the tube.All information reasonably known as of 18-sep-2025 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.

• Brand Name: CORTRAK 2 NG/NI FEEDING TUBE W/ ELECTROMAGNETIC TRANSMITTING STYLET
• 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: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 22106257
• Report Number: 9611594-2025-00113
• Device Sequence Number: 12518281
• Product Code: KNT
• UDI-Device Identifier: 00350770460475
• UDI-Public: (01)00350770460475
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 40-9431TRAK2
• Device Catalogue Number: 40-9431TRAK2
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2025
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 06/03/2025; 08/25/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 07/02/2025; 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 60CC SYRINGES; ALKALINIZED ENZYME; FEEDING PUMP; TYLENOL TABLET & MILK OF MAGNESIUM
• Patient Sex: Female