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

Model Number	42-9368
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Feeding Problem (1850); Cough (4457)
Date of Event	04/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, ¿feed noted to be coming from tracheostomy site, upon investigating it was noticed a puncture/cut into the nasogastric feeding tube.Patient who had max-fax surgery, tracheostomy and nasogastric tube insertion for feeding done on the (b)(6) 2024.Feeding tube was confirmed by chest x-ray and was determined safe to use by doctor.Once feeding started, the feed was noted to be coming from the tracheostomy site.Patient at risk for aspiration of feed into the lungs.¿ it was additionally reported, ¿equipment removed from patient.Equipment quarantined.Chest x-ray performed to patient.Tracheal cuff kept inflated and patient was nursed in an upright position.Started on antibiotics.Patient was informed and re-assured.Medical decision to start parenteral nutrition instead of enteral nutrition due to risk related to new nasogastric insertion.¿.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 22 may 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
All information reasonably known as of 31 may 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 comp (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 product involved in the report has been returned and the investigation remains in progress at this time.All information reasonably known as of 08 jul 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
Additional information: d4, h4, h6.The device history record for lot: 20041434 was reviewed and the product was produced according to product specifications.The actual complaint product was returned for evaluation.Subject sample provided was evaluated confirming that the tubing had signs of damages (tear/hole).This area of the tubing was cut to view the inside surface of the tubing.Once the tubing was opened, there were lines and indentations in the inner walls of the tubing that was observed.However, there were no found activities or tools that could cause this type of flaw in the tube component; the cause for this incident could not be determined.All information reasonably known as of 17 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: 19383073
• Report Number: 9611594-2024-00087
• Device Sequence Number: 3785160
• Product Code: KNT
• UDI-Device Identifier: 00350770460925
• UDI-Public: (01)00350770460925(240)120001484(11)230622(17)260621(10)20041434
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/17/2025

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: Lay User/Patient
• Device Expiration Date: 09/24/2025
• Device Model Number: 42-9368
• Device Catalogue Number: N/A
• Device Lot Number: 20041434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/01/2024
• Supplement Date Received by Manufacturer: 05/24/2024; 06/21/2024; 06/27/2025
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 06/11/2024; 07/11/2024; 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2020
• 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: TRACHEOSTOMY.
• Patient Age: 63 YR
• Patient Sex: Male