MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO NASOINTESTINAL ENDOSCOPICALLY PLACED FEEDING TUBE; DH CPK NI (NASOINTESTINAL) FEEDING TUBES

Model Number	51-9601
Medical Device Problem Codes	Complete Blockage (1094); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Vomiting (2144)
Date of Event	11/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event was initially deemed not reportable based on our reporting strategy active at the time of the alert date; however, following a recent retrospective review of complaints this event was made reportable out of an abundance of caution.A review of the device history record is not possible as no lot number was provided; therefore, the udi-pi is unavailable.The actual complaint product was not returned for evaluation.However, a photo was provided.The visual evidence confirmed the knot in the tube.A root cause has not been established.All information reasonably known as of 05 may 2026 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 that a patient was in the er with a problem with the corflo tube.She suffered a little more from blockages in the tube in recent weeks.Yesterday she vomited and a large part of the tube was luxated.Given the significant luxation, she wanted to pull out the tube herself, but this was met with resistance.Home care and ambulance also visited her during the night, but were unable to remove the tube.She did experience increasing pain in her nose.During assessment, the tip of the was noted in the throat and they decided to remove the probe (although some nosebleeds afterwards).A knot was found at the end of the tube.

• Brand Name: CORFLO NASOINTESTINAL ENDOSCOPICALLY PLACED FEEDING TUBE
• Common Device Name: DH CPK NI (NASOINTESTINAL) FEEDING TUBES
• 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 84048 ; MX 84048
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 25081186
• Report Number: 9611594-2026-00277
• Device Sequence Number: 10695288
• Product Code: KNT
• UDI-Device Identifier: 00350770462325
• UDI-Public: (01)00350770462325
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K882867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

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
• Device Model Number: 51-9601
• Device Catalogue Number: 51-9601
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 11/03/2024
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female