MAUDE Adverse Event Report: Avanos Medical, Inc. AVANOS; Tubes, gastrointestinal (and accessories)

Model Number	40-7431
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A potential human factors/design concern: a dobhoff (corflo enteral feeding tube) was inserted overnight with the stylet left in place following insertion.It is unknown whether the retained stylet was recognized during subsequent nursing assessments.The issue was identified the following day when the patient underwent an mri examination.After completion of the scout image and first imaging sequence, mri technologists noted image artifact and questioned whether the patient had any metal associated with the feeding tube.An additional sequence was attempted; however, due to continued artifact, the patient was slowly removed from the scanner for further assessment.The patient denied having any implanted facial metal or other metallic objects.The mri team asked the patient's nurse to inspect the feeding tube.Upon examination, the nurse discovered that the stylet remained in the dobhoff tube.The stylet was immediately removed and discarded in a sharps container.The patient had been in the mri scanner approximately 3 to 5 minutes before the retained stylet was identified.The radiologist was notified and confirmed that imaging could proceed following stylet removal.The patient reported no discomfort, injury, or adverse symptoms.No evidence of harm was identified.A potential contributing factor identified during event review was the design of the feeding tube assembly.The stylet port and feeding tube port are the same color and appear similar, making it difficult to visually identify when the stylet remains in place.This may be especially challenging when different staff members are involved in tube insertion, x-ray confirmation, and subsequent patient care.The retained stylet was not recognized until mri image artifact prompted further investigation.This raises a potential usability concern related to visual differentiation of components and detection of retained stylets during care handoffs.

• 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: 50896933
• Report Number: 50896933
• Device Sequence Number: 5828876
• Product Code: KNT
• UDI-Device Identifier: 00350770460321
• UDI-Public: (01)00350770460321
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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): 08/14/2026
• Report Date (Section F): 08/14/2026

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: 40-7431
• Device Catalogue Number: 40-7431
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/14/2026