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

Model Number	6-1222-ISOSAF
Medical Device Problem Codes	Break (1069); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Per the original reporter in medwatch report #s: mw5186468 and mw5186469, it was reported that, "the amt mini enteral extension set is breaking while in the patient's g tube.The part of the amt that inserts into the g tube is breaking off while the connection tubing is being taken off and on the patient.This has happened twice to this same patient within a week.This event was reported to the amt vendor representative".
Additional Manufacturer Narrative
This report is a response to report #s mw5186468 and mw5186469 which were received by amt from the fda on 04/27/2026.The occurrence was originally reported to amt on (b)(6) 2026 by (b)(6).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.Since the devices were not available for return, a visual and functional evaluation could not be performed, and device failures could not be confirmed.Based on the provided information the reported problem is not believed to have been caused by a manufacturing defect.The complaint information has been logged into our complaint database for trending purposes.Information regarding device investigation can be found under complaint # (b)(4).

• Brand Name: AMT MINI EXTENSION SET
• Common Device Name: 12" RIGHT ANGLE FEEDING SET WITH DUAL ENFIT® 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 dipaolo ; 8006 katherine boulevard; brecksville, OH 44141 ; 4402622539
• MDR Report Key: 25243758
• Report Number: 1526012-2026-00009
• Device Sequence Number: 10548480
• Product Code: PIF
• UDI-Device Identifier: 00842071140069
• UDI-Public: 00842071140069
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2026

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: 6-1222-ISOSAF
• Device Catalogue Number: 6-1222-ISOSAF
• Device Lot Number: 260305-090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 05/21/2026
• 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: 11 MO
• Patient Sex: Male
• Patient Weight: 6 KG
• Patient Race: White