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	03/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is a response to report # mw5186451 which was received by amt from the fda on 04/27/2026.The occurrence was originally reported to amt on (b)(6) 2026 by the same initial reporter.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.Gastrostomy devices and their accessories are disposable and are meant to be exchanged.The reported intervention to replace the gastrostomy device was not to prevent permanent, irreversible, impairment or damage to a body function or structure.Since the devices were not returned, a visual and functional evaluation could not be performed, and device failures could not be confirmed.Note, both gastric and jejunal extension sets are tested to the same specifications.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).
Event or Problem Description
Per the original reporter in medwatch report #: mw5186451, it was reported that, "my baby, (b)(6), has an amt gjet tube.The g connectors, (not the j's), keeping repeatedly breaking and getting stuck inside the port.The extension that keeps breaking is called 12" right angle feeding set with dual enfit y-port.My baby is constantly being put to sleep to get a new one.We aren't sure how or why it's happening.We are screwing it in properly (line it up with the line and turn it clockwise to lock).We always make sure it's secure and locked in place.The j connectors are differently quality than the g's.I beleive it's breaking because the g connectors are cheap poor-quality plastic.We came across multiple posts with this happening and i posted as well.It seems like multiple reports have been made but nothing ever gets done about it".

• 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: 25244364
• Report Number: 1526012-2026-00010
• Device Sequence Number: 18532643
• 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
• Initial Reporter Occupation: Other
• 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: Lay User/Patient
• Device Model Number: 6-1222-ISOSAF
• Device Catalogue Number: 6-1222-ISOSAF
• Device Lot Number: 250902-353
• Was Device Available for Evaluation?: No
• 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: 10 MO
• Patient Sex: Male
• Patient Weight: 6 KG
• Patient Race: White