MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO NG FEEDING TUBE WITH STYLET; DH CPK NG TUBES

Model Number	20-9432
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for the reported lot number, 30217846, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The actual complaint product was not returned for evaluation.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 halyard health 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 halyard health.(b)(6) 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 halyard health 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 a halyard health product is defective or caused serious injury.
Event or Problem Description
It was reported "the main hole of the product connected to the guide wire; the blue tip of the guide wire has a small gap so the medical staff cannot pump water and air smoothly.New tube inserted." there was no reported injury.

• Brand Name: CORFLO NG FEEDING TUBE WITH STYLET
• Common Device Name: DH CPK NG 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: 24903771
• Report Number: 9611594-2026-00216
• Device Sequence Number: 13218491
• Product Code: KNT
• UDI-Device Identifier: 10350770457991
• UDI-Public: (01)10350770457991(240)104579902(17)270815(10)30217846
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K821906
• 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,Distributor
• 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: 20-9432
• Device Catalogue Number: 20-9432
• Device Lot Number: 30217846
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2024
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown