MAUDE Adverse Event Report: KENTEC MEDICAL AMERITUS ENTERAL FEEDING TUBE

Model Number	AEG-40P-50
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Customer states that the tab to open the cap is breaking off.

• Brand Name: AMERITUS ENTERAL FEEDING TUBE
• Common Device Name: FEEDING TUBE
• Manufacturer (Section D): KENTEC MEDICAL; 17871 fitch; irvine CA 92614
• MDR Report Key: 6918175
• Report Number: 2080225-2017-08011
• Device Sequence Number: 807846
• Product Code: FPD
• UDI-Device Identifier: 10817522011073
• UDI-Public: 10817522011073
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K100526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2017

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: No Information
• Device Expiration Date: 02/01/2021
• Device Model Number: AEG-40P-50
• Device Catalogue Number: AEG-40P-50
• Device Lot Number: 602103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 1 WK