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

Model Number	OC-ENT-060
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A 60-inch enteral feeding extension set was primed for infant feeding and found to have a pinhole leak on the side of the female connector of the tubing.

• Brand Name: AMERITUS
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): KENTEC MEDICAL, INC.; 17871 fitch; irvine CA 92614
• MDR Report Key: 20682240
• Report Number: 20682240
• Device Sequence Number: 8557390
• Product Code: KNT
• UDI-Device Identifier: 10817522011325
• UDI-Public: (01)10817522011325(17)270228(10)KS2403008
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 10/17/2024
• Report Date (Section F): 10/17/2024

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: OC-ENT-060
• Device Catalogue Number: OC-ENT-060
• Device Lot Number: KS2403008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2024
• 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: Unknown
• Date Report Sent to FDA: 10/17/2024