MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO NASOGASTRIC/NASOINTESTINAL PEDIATRIC FEEDING TUBE; DH CPK NG TUBES

Model Number	40-8368
Medical Device Problem Codes	Material Rupture (1546); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that while flushing a corflo pediatric feeding tube that had been in place for approximately 6 weeks, the patient experienced pain and felt that the tube had "popped." the tube was removed and a 1¿2 cm section of the tubing was found to be ballooned.The tube was replaced with a new device.The reporting facility indicated the tube may have become blocked by crushed medication and that forceful flushing may have caused the ballooning.The tube had been discarded; only a photograph was available.No patient injury was reported.
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.Sample evaluation could not be performed because the device was not returned.A photograph of the reported device was provided; however, the reported condition could not be confirmed or duplicated through functional evaluation.A review of the device history record is not possible as a valid lot number was not provided; therefore, the udi-pi is unavailable.Root cause could not be determined.The reported device was not returned for evaluation and a valid lot number was not provided, preventing sample evaluation and device history record review.Therefore, the reported ballooning condition could not be confirmed or duplicated.All information reasonably known as of 29 jun 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.

• Brand Name: CORFLO NASOGASTRIC/NASOINTESTINAL PEDIATRIC FEEDING TUBE
• 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: 25664647
• Report Number: 9611594-2026-00510
• Device Sequence Number: 21407179
• Product Code: KNT
• UDI-Device Identifier: 00350770460376
• UDI-Public: (01)00350770460376
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K831328
• 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): 06/29/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 40-8368
• Device Catalogue Number: 40-8368
• 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: 09/02/2024
• Initial Report FDA Received Date: 06/30/2026
• 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
• Patient Sex: Unknown