MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO NG/NI FEEDING TUBE WITH STYLET, ENFIT CONNECTOR; DH CPK NG TUBES

Model Number	42-7361
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the "tube breaks, used 1-month." there was no reported injury.There was no reported injury.
Additional Manufacturer Narrative
The actual complaint product was returned for evaluation.A review of the device history record and udi number are in-progress.All information reasonably known as of 21-nov-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.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30283359, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The device was evaluated.Prior to decontamination, the sample was photographed to show the appearance how it was received.The sample device was examined showing that the tubing had signs of damage and slight discoloration.During cleaning and decontamination, a slight build-up/ discoloration from the outer tubing was attempted to be removed by scrubbing the tubing with lint free towel using tergazyme and soaked in metricide solution.The tube was also flushed through the y-connector (proximal end).Resistance was not felt while flushing and the solution came out of the opening by the proximal end.There was a split/tear identified approximately at the 14cm marking.At the 14cm 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 other piece that broke off was not returned with the sample.The used tubing also appeared to have blurry tube information and incremental markings.When manually pressing the tubing back together, there were thin layers of the material noticed on the ballooned portion of the tube.The breaking point was examined, and no dried foreign material residues observed, however, the staining on tube remains visible.The sample was examined under magnification.The sample provided confirmed the tubing expanded to form a balloon shape which burst causing a separation of the tube.Root cause could not be determined.All information reasonably known as of 05-feb-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.

• Brand Name: CORFLO NG/NI FEEDING TUBE WITH STYLET, ENFIT CONNECTOR
• 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
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 23625000
• Report Number: 9611594-2025-00295
• Device Sequence Number: 13019693
• Product Code: KNT
• UDI-Device Identifier: 00350770460802
• UDI-Public: (01)00350770460802(240)104608002(17)280924(10)30283359
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2026

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: 42-7361
• Device Catalogue Number: 42-7361
• Device Lot Number: 30283359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2025
• 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: 10/22/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2023
• 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