MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. MINI ONE; ENTERAL EXTENSION SET

Model Number	8-2455
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is a response to medwatch report # mw5100424 which was received by amt from the fda on 04/27/2021.Based on the provided information, the incident is not a reportable event per 21 cfr section 803.There was no death.There was no serious injury, as defined by the fda.This was not life-threatening, nor did this result in permanent impairment or necessitate medical or surgical intervention to preclude permanent impairment.The reported indicated that the patient was not harmed.Amt is has reached out to the reporter in an attempts to obtain the device for examination.The device has not returned at this time, therefore a visual and functional evaluation could not be done.However, a device history review was performed as the lot number was provided, with no anomalies found.We will continue to work with the reporter in attempts to retrieve additional information regarding this report and the device for examination.We will provide additional information to the fda if the device or additional information is able to be obtained and analysis changes the conclusion of this report.Amt has assigned complaint #: (b)(4)to track this record.
Event or Problem Description
This report is in response to initial report #mw5100424, which provided that the mini one 24" right angle feeding set with y-port y port separated from tubing when disconnecting syringe from y port.No obvious cuts or damage seen to naked eye.Patient not harmed.Gastric contents emptied into bed.

• Brand Name: MINI ONE
• Common Device Name: ENTERAL EXTENSION SET
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville OH 44141
• MDR Report Key: 11890598
• Report Number: 1526012-2021-00014
• Device Sequence Number: 11000028
• Product Code: KNT
• UDI-Device Identifier: 00842071109028
• UDI-Public: (01)00842071109028(17)231101(10)201123-081
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/26/2021

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: 11/01/2023
• Device Model Number: 8-2455
• Device Catalogue Number: 8-2455
• Device Lot Number: 201123-081
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1