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

Model Number	40-8368
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Feeding Problem (1850)
Date of Event	03/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, ¿ng (nasogastric) tube had a hole in it near the enfit attachment place; additional imaging obtained, and new tube placed.Ng tube had a hole in it near the enfit attachment place.As a result, the patient received a xray and all meds and feeds were late.Not to mention, we had to place an additional ng tube.(that was the 8th that shift).', device was in use for patient care, no concurrent device usage that would contribute to the failure.".
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 returned for evaluation which revealed a grouping of jagged tears was observed in the tubing, near the connector.A process review was conducted to evaluate the potential causes for this failure mode but, no inconsistencies were found.A root cause could not be determined all information reasonably known as of 02 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 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 FEEDING TUBES
• 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: 24236017
• Report Number: 9611594-2026-00037
• Device Sequence Number: 10229529
• Product Code: KNT
• UDI-Device Identifier: 00350770460376
• UDI-Public: (01)00350770460376
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2026

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: 40-8368
• Device Catalogue Number: 40-8368
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2025
• 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: 03/26/2025
• Initial Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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