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

Model Number	51-9601
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for the reported lot number: 30252010, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The sample was received with an opened original packaging.A guidewire, extra yellow tubing without markings and the enfit yellow tubing that appeared to have some sort of damage just below the y-connector port.Upon receipt the yellow tubing with the enfit connector port was examined and observed to have splitting just below the y-connector port.The tube was examined under magnification; there was a partial splitting identified below the y-connector.The area where the split located appeared to have jagged appearance.Root cause could not be determined.All information reasonably known as of 14-apr-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 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 or Problem Description
It was reported "when rinsing the corflo probe (with water), it turned out that there was a crack in the probe, just below the y-point.This made this probe unusable." there was no reported injury.

• Brand Name: CORFLO NI 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: 24903769
• Report Number: 9611594-2026-00211
• Device Sequence Number: 9827406
• Product Code: KNT
• UDI-Device Identifier: 00350770462325
• UDI-Public: (01)00350770462325(240)104523202(17)280402(10)30252010
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2026

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: 51-9601
• Device Catalogue Number: 51-9601
• Device Lot Number: 30252010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2023
• 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
• Patient Sex: Unknown