MAUDE Adverse Event Report: KENTEC MEDICAL, INC. AMERITUS; TUBE, FEEDING

Model Number	AEG-60P-80
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Several incidents of neonatal feeding tube cap breakage requiring removal and replacement of feeding tubes.Manufacturer response for tube, feeding, ameritus (per site reporter) unknown.

• Brand Name: AMERITUS
• Common Device Name: TUBE, FEEDING
• Manufacturer (Section D): KENTEC MEDICAL, INC.; 17871 fitch; irvine CA 92614
• MDR Report Key: 20891539
• Report Number: 20891539
• Device Sequence Number: 12742852
• Product Code: FPD
• UDI-Device Identifier: 10817522011967
• UDI-Public: (01)10817522011967
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/03/2024
• Report Date (Section F): 12/03/2024

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
• Device Model Number: AEG-60P-80
• Device Catalogue Number: AEG-60P-80
• Device Lot Number: KS2404004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/10/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/10/2024
• 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: Female
• Date Report Sent to FDA: 12/03/2024