MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. AMT MINI ONE® EXTENSION SET; 12" MINI ONE® RIGHT ANGLE FEEDING SET WITH Y-PORT

Model Number	8-1255
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is a response to report # (b)(4) which was received by amt from the fda on 07/28/2025.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.Amt reached out to the reporter in attempts to retrieve the device for examination.The reporter indicated that the device was not available for return.Since the device was not returned, a visual and functional evaluation could not be performed, and device failure could not be confirmed.A device history review found no defects and no similar complaints have been reported from the same manufactured batch.Based on the provided information the reported problem is not believed to have been caused by a manufacturing defect.Complaint # (b)(4) was assigned to this report.We will provide additional information to the fda if additional information is able to be obtained and its analysis changes the conclusion of this report.
Event or Problem Description
Per the original reporter in medsun report #:(b)(4), it was reported that, "no harm to patient.J [jejunostomy] tube extension broken at med [medication] port".

• Brand Name: AMT MINI ONE® EXTENSION SET
• Common Device Name: 12" MINI ONE® RIGHT ANGLE FEEDING SET WITH Y-PORT
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville OH 44141
• Manufacturer (Section G): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville OH 44141
• Manufacturer Contact: ellyn smith ; 8006 katherine boulevard; brecksville, OH 44141 ; 4402622539
• MDR Report Key: 22882877
• Report Number: 1526012-2025-00014
• Device Sequence Number: 13171869
• Product Code: KNT
• UDI-Device Identifier: 00842071108786
• UDI-Public: 00842071108786
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/25/2025

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: 8-1255
• Device Catalogue Number: 8-1255
• Device Lot Number: 240910-148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 12 MO
• Patient Sex: Female