MAUDE Adverse Event Report: AVANOS MEDICAL, INC. NEOMED ENFIT PU FEEDING TUBE ORANGE 6.5FR 60CM; TUBE, FEEDING

Model Number	FTM6.5P-NC
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was to have an ng placed and the nurse obtained the neomed feeding tube with enfit connector.Before opening the package, the nurse noted it did not contain the cap piece to the catheter which made it so that the catheter could not be clamped off.The tube was not useable.Has been reported that this is not the first tube that did not have a cap.

• Brand Name: NEOMED ENFIT PU FEEDING TUBE ORANGE 6.5FR 60CM
• Common Device Name: TUBE, FEEDING
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 16271592
• Report Number: 16271592
• Device Sequence Number: 7492741
• Product Code: FPD
• UDI-Device Identifier: 00350770000619
• UDI-Public: 00350770000619
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/17/2023
• Report Date (Section F): 01/17/2023

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: FTM6.5P-NC
• Device Catalogue Number: FTM6.5P-NC
• Device Lot Number: TY220703
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/17/2023