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 Code	Break (1069)
Health Effect - Clinical Codes	Feeding Problem (1850); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/25/2026
Type of Reportable Event	Malfunction

• 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: cameron rogal ; 8006 katherine boulevard; brecksville, OH 44141
• MDR Report Key: 50212873
• Report Number: 1526012-2026-00013
• Device Sequence Number: 15931581
• Product Code: PIF
• UDI-Device Identifier: 00842071140069
• UDI-Public: 00842071140069
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Consumer
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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: Lay User/Patient
• Device Model Number: 6-1222-ISOSAF
• Device Catalogue Number: 6-1222-ISOSAF
• Device Lot Number: 260505-111 & 260608-263
• 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: 07/13/2026
• Initial Report FDA Received Date: 08/11/2026
• 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: 13 MO
• Patient Sex: Male
• Patient Weight: 13 LB
• Patient Race: White