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

Model Number	42-9225
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual sample from the reported event was returned for evaluation.A review of the device history record is not possible as no lot number was provided; therefore, the udi-pi is unavailable.The lot number was not provided by the customer.All information reasonably known as of 10-jan-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 event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint comp-ghc-24-06487.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 the feeding tube was noted to be transected on the morning x-ray examination.The provider came to the "patient's bed side" and the feeding tube was removed with 10cm of the broken device remaining inside the patient.An egd (esophagogastroduodenoscopy) was performed at the patient's bedside and the patient tolerated the procedure well.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.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 event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.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
H6 investigation findings/appropriate term/code not available: inappropriate use.The received sample was not returned with the original packaging.Prior to decontamination, the sample was photographed to show the appearance how it was received.The sample device was examined showing that the tubing had sign of damage and slight discoloration.During cleaning and decontamination, a slight build-up/ discoloration from the outer tubing was noted an attempt was made to remove it by scrubbing the tubing with a lint free towel using tergazyme and soaked in metricide solution.The tube was also flushed through the y-connector (proximal end), slight resistance was felt while flushing, and some brownish substances were flushed out of the tube after couple attempts.At the 9cm marked location, the tubing appeared to have expanded to form a balloon shape which burst in multiple direction causing a separation of the tube into two pieces.When manually pressing the tubing back together, there were thin layers of the material noticed on the ballooned portion of the tube.Both breaking points were noted to not have dried foreign material residue stuck inside the tubing.Since the tubing was not clogged or blocked after decontamination, there was no need to open the tubing to inspect the surface of the tubing wall for any obstruction appearances.The subject sample provided was evaluated confirming a ballooning area with an axial split located approximately 9cm marked location.Both breaking points exhibited to not have dried foreign material residue stuck inside the tubing.The root cause of the reported issue seems to be a user related problem since as per the ifu (instructions for use), vigorous syringe force should not be used to irrigate, administer liquids, or unblock the tube.All information reasonably known as of 08-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 event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.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 NG/NI FEEDING TUBE WITH STYLET WITH 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: 21130000
• Report Number: 9611594-2025-00001
• Device Sequence Number: 15332774
• Product Code: KNT
• UDI-Device Identifier: 00350770460857
• UDI-Public: (01)00350770460857
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2025

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: ANP
• 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: 12/10/2024
• Supplement Date Received by Manufacturer: 01/24/2025; 07/08/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/20/2025; 07/08/2025
• 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
• Patient Age: 1 MO
• Patient Sex: Female