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

Model Number	40-9431
Medical Device Problem Codes	Fracture (1260); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, ¿dobhoff tube required de-clogging between 5a-6a, lipase was used and the nurse was able to de-clog, however when she was finishing de-clogging, she noted her next flush was very difficult and she was concerned that the dobhoff tube was displaced.So, i ordered an abdominal x-ray for confirmation.Abdominal x-ray revealed that the dobhoff tube was fractured in the stomach at about 35 cm above the bottom tip.I removed the dobhoff tube per gastrointestinal (gi) recommendations and was able to retrieve the entire tube.The fracture was to the internal portion of the tube making it unusable, however a portion of the outer tube (the flexible covering) was still intact and distorted, presumably due to expansion during flushing.¿ no harm to patient.
Additional Manufacturer Narrative
A review of the device history record is not possible as no lot number was provided; therefore, the udi-pi is unavailable.The product involved in the report has been returned and the investigation remains in progress at this time.All information reasonably known as of (b)(6) 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 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.
Additional Manufacturer Narrative
The actual complaint product was returned for evaluation.The sample device was examined showing that the tubing had signs of damage and discoloration.There was a split/tear identified approximately between 42cm and 40cm.The tubing appeared to have expanded to form a balloon shape which burst axially causing an opening which will make the tube unable to function.The tubing was cut and opened to inspect the inner surface of tubing walls.From 40cm marking until bolus end tip, brownish substance residues were stuck in the tube.The root cause of the reported issue seems to be a user related problem since as per the ifu, vigorous syringe force should not be used to irrigate, administer liquids, or unblock the tube.All information reasonably known as of 10 jul 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 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
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 21306099
• Report Number: 9611594-2025-00020
• Device Sequence Number: 8244190
• Product Code: KNT
• UDI-Device Identifier: 00350770460468
• UDI-Public: (01)00350770460468
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

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: 40-9431
• Device Catalogue Number: 40-9431
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 07/11/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LIPASE.
• Patient Sex: Unknown