MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. 12¿ Right Angle Clear Dual ENFit® Y-Port Extension Set; Tubes, Gastrointestinal (And Accessories)

Model Number	6-1222-ISOSAF
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250); Difficult to Open or Close (2921)
Health Effect - Clinical Codes	Gastritis (1874); Hypoglycemia (1912); Low Blood Pressure/ Hypotension (1914); Vomiting (2144)
Date of Event	08/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
I have an amt gjet tube (18fr, 3.5, 45 length).I am on 18hr continuous j-tube feeds.I receive some medications via my g-tube.I was connected to both g and j extensions when i started throwing up, and the tip of the g extension broke off into the tube.I called the interventional radiology and gi teams, who directed me to the ed.Since the g port could not be shut, i was leaking gastric contents out and developed a stomach acid burn on my hypogastric region.Over the next couple weeks, two more g extensions broke into the port.I had another ed visit, then ultimately needed a complete tube replacement on (b)(6) 2026 as the valve was broken (secondary to the extension breaking).I required ed & medical help to prevent further stoma complications and infection, and to minimize risk of metabolic or hemodynamic instability as i receive medications via my tube to prevent hypoglycemia & hypotension.I had several episodes of severe hypoglycemia due to leakage of the g port (when pushing glycosade) and after the tube replacement, had two episodes of hypotension (67/37 and 74/45).I no longer have the three broken extensions as amt requested that i ship them back to them, so i did.The extensions are the 12" right angle clear dual y port enfit extensions.They were supplied to me that month by optioncare.Refer to additional documents in i2k.Referenced reports: mw6002164, mw6002165.Annex a- 1069,1250,2921.Annex e- 2144,1874,1912,1914.Annex f-4629,4607.Annex g-525.This report captures- 12¿ right angle clear dual enfit®y-port extension set #1.

• Brand Name: 12¿ Right Angle Clear Dual ENFit® Y-Port Extension Set
• Common Device Name: Tubes, Gastrointestinal (And Accessories)
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.
• MDR Report Key: 50732447
• Report Number: MW6002163
• Device Sequence Number: 20956047
• Product Code: KNT
• UDI-Device Identifier: 00842071140069
• UDI-Public: (01)00842071140069
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 09/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 6-1222-ISOSAF
• Device Lot Number: 260513-530
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2026
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Required Intervention; Other; Hospitalization
• Patient Sex: Female
• Patient Weight: 100 LB
• Patient Race: Asian