MAUDE Adverse Event Report: AVANOS MEDICAL, INC. AVANOS; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	40-9438
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
B [background]: has had multiple feeding tubes with clogging issues.Last tube placed in ir [interventional radiology] on [date redacted].On [date redacted] - approximately 2.5 weeks after last feeding line was placed, rn noted feeding pump alarming, unable to flush nd [nasoduodenal] tube, md notified.Contrast given at bedside and found tube disrupted with contrast filling stomach, proximal part of tube in stomach and distal part of tube in duodenum.A: unintentionally retained foreign object.Per unit cns [clinical nurse specialist], tube was managed per standards.When meds administered, crushed, diluted, flushed appropriately, use of "clog zapper" when noted tube flushing sluggishly.Of note patient does not receive many meds through tube, last med administered 3 hours prior to clogging episode.R: continue to follow standard crushing, diluting, flushing guidelines when administering meds.To ir tomorrow for removal of retained tube and placement of nd tube.The ngt [nasogastric tube] device burst open while in place.Part of the ngt was retained in the patient's stomach.Viscous feeds are likely clumping up in the ngt.The ngt burst while inside the patient.The tube was clogged, and the built-up pressure burst the tube.Patient has to go to ir to recover the retained foreign object.Tube is still in place; ir will remove the tube and replace with new tube for use.

• Brand Name: AVANOS
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 22827361
• Report Number: 22827361
• Device Sequence Number: 4431744
• Product Code: KNT
• UDI-Device Identifier: 00350770460505
• UDI-Public: (01)00350770460505
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2025
• Report Date (Section F): 08/06/2025

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
• Device Model Number: 40-9438
• Device Catalogue Number: 40-9438
• Device Lot Number: 30298711
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/18/2025
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 3 MO
• Patient Sex: Male
• Date Report Sent to FDA: 08/06/2025