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

Model Number	42-9225
Medical Device Problem Codes	Break (1069); Obstruction of Flow (2423)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, ¿broken tube in the stomach of the baby.The tube was placed without any problems.They administered a bolus of water with some resistance and when the tube was connected to the tube, the pump did not indicate pressure.¿ the tube was found to be broken.The retained portion of the tube was removed via endoscopy.The tube was in use for 15-30 days.Per additional information received on 30jul2024, the patient is stable and at home.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record and udi are in-progress.All information reasonably known as of 19 aug 2024 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 device history record for lot 30250912 was reviewed and the product was produced according to product specifications.The picture provided confirms tubing expanded to form a balloon shape which burst causing a separation of the tube.However, a root cause could not be determined.All information reasonably known as of 15 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 TUBE W/ STYLET W/ 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: 20010828
• Report Number: 9611594-2024-00162
• Device Sequence Number: 4362931
• Product Code: KNT
• UDI-Device Identifier: 00350770460857
• UDI-Public: (01)00350770460857(240)104608502(17)280402(10)30250912
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: 42-9225
• Device Catalogue Number: 42-9225
• Device Lot Number: 30250912
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2023
• 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 Age: 2 MO
• Patient Sex: Male
• Patient Weight: 3 KG