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

Model Number	42-9366
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device is reported to be available but has not been 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 12-sep-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 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.
Event or Problem Description
It was reported there was a "broken tube in the stomach of the [patient].A [patient] who underwent a liver transplant, when they did an x-ray for other reasons, they detected in the image that the tip is connected by a thread to the rest of the tube.The tube has been in place for 22-days and no one has noticed anything, it has been permeable at all times, and they have not noticed any resistance in the administration of nutrition or medication." there was no reported injury.
Additional Manufacturer Narrative
The actual device was returned and evaluated.The received sample was not returned with the original packaging.Prior to decontamination, the sample was examined to understand the appearance how it was received.The sample device was showing that the tubing had signs of damage and slight discoloration.During cleaning and decontamination, some build-up/ discoloration from the outer tubing was tried to be remove by scrubbing the tubing with lint free towel using tergazyme and soaked in metricide solution.The tube was also flushed through the y connector (proximal end).While flushing, no substances were flushed out of the tube, the liquid solution came out of the tube with no issue.The small part of the distal end that were hanging by a thread completely separated by accident while cleaning the tube.This area was not occluded, it was able to flush.The ballooning identified approximately 5mm before bolus end tip.The entirety of the tube appeared slight discoloration.At the torn marking location (5mm before bolus end tip, the tubing appeared to have expanded to form a ballooning in the tube then burst and torn.When inspecting under magnification (20x), there were thin layers of the material noticed on the expanded portion of the tube.Both breaking points were inspected and did not see any build-up residue.However, when feeling the tubing further, it was difficult to identify the hardened portion due to the size of tubing being small.The tubing was cut and opened to inspect the inner surface of tubing walls.From y-connector port until end tip of proximal end, there were no build-ups seen inside the tubing.Under magnification, after dissection, tubing was inspected and there was no excess embedded material.Root cause could not be determined.All information reasonably known as of 15-oct-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 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 NASOGASTRIC/NASOINTESTINAL FEEDING TUBE, STYLET, 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: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 20202963
• Report Number: 9611594-2024-00195
• Device Sequence Number: 20714334
• Product Code: KNT
• UDI-Device Identifier: 00350770460918
• UDI-Public: (01)00350770460918
• 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: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2024

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: 42-9366
• Device Catalogue Number: 42-9366
• Device Lot Number: UNKNOWN
• 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: 08/14/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 10/15/2024
• 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: 3 MO
• Patient Sex: Male