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

Model Number	40-9438
Medical Device Problem Codes	Break (1069); Obstruction of Flow (2423)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
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 25 feb 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.
Event or Problem Description
It was reported, "patient's feeding pump alarmed with clogged line and upon assessment, bedside nurse decided to attempt declotting line.First with enfit 35 ml syringe but was ineffective so upon suggestion of charge rn, used a 5 ml syringe with soda attempted but upon attempt to flush, heard a pop inside patient's nostrils.In attempt to discontinue dobhoff and pull ng out, only a few cm's was pulled out and the rest of the tube still inside patient.Dr in micu team made aware.Cns aided with using tongue depressor to assess patient's throat and using a chest tube clamp, was able to retrieve and pull out the rest of the remaining dobhoff tube from patient's throat.".
Event or Problem Description
Per additional information received on 11mar2025, the tube was placed on (b)(6) 2025.Tube was flushed every four hours.Many medications came in solution form already and if not, was dissolved in water completely before administration.No harm had reached the patient as we were able to pull out the other part of tubing.Another tube was placed after the event.Patient was discharged days later in a stable condition.
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 01 apr 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 device history record for the reported lot number, 30329792, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The sample provided was evaluated and confirmed tubing expanded to form a balloon shape which burst causing a separation of the tube.The instructions for use (ifu) contains recommendations for tube maintenance: ¿it is recommended the tube be irrigated every 4 hours with up to 20 ml of water (up to 10 ml for infants or children) before and after medication administration or when feeding formula is interrupted.Warning: vigorous syringe force should not be used to irrigate, administer liquids or unblock the tube.¿ root cause could not be determined.All information reasonably known as of 28-aug-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: 21470071
• Report Number: 9611594-2025-00035
• Device Sequence Number: 8658433
• Product Code: KNT
• UDI-Device Identifier: 10350770460502
• UDI-Public: (01)10350770460502(240)104605002(17)290610(10)30329792
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2025

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: 40-9438
• Device Catalogue Number: 40-9438
• Device Lot Number: 30329792
• 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: 01/29/2025
• Supplement Date Received by Manufacturer: 03/11/2025; 07/29/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 04/01/2025; 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2024
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 55 KG