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); Leak/Splash (1354); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is a response to report # mw5176512 which was received by amt from the fda on 10/17/2025.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.G-jet devices are disposable and are meant to be exchanged.Please note all g-jet exchanges require surgical intervention whether planned or unplanned.The reported intervention to replace the g-jet device was not to prevent permanent, irreversible, impairment or damage to a body function or structure.The complaint was initially reported to amt on (b)(6) 2025 by the risk manager of pediatric home service.At this time, it was indicated that the device was not available for return as it had been discarded.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.
Event or Problem Description
Per the original reporter in medwatch report #: mw5176512, it was reported that, "the part of the extension that goes into the g port of the g-jet is breaking off and it is unable to be removed.When this happens, they are unable to close the port and gastric contents quickly leak out.Ultimately it requires urgent surgical intervention to replace the g-jet.Dad notes that he was able to get the piece out one of the times, but the other two times required placement of a new g-jet." item discarded by medical providers at time of intervention and unable to return.Writer manages product complaint platform and this is the 4th complaint for this item this year.This is the first time significant medical intervention was required to address the issue but risk of harm and being unable to remove the pieces once broken were present in 2 of the other complaints entered as well".

• 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: 23479581
• Report Number: 1526012-2025-00016
• Device Sequence Number: 10499507
• Product Code: PIF
• UDI-Device Identifier: 00842071140069
• UDI-Public: 00842071140069
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/05/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: 6-1222-ISOSAF
• Device Catalogue Number: 6-1222-ISOSAF
• Device Lot Number: 250828-297
• 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: 10/17/2025
• Initial Report FDA Received Date: 11/05/2025
• 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: 9 YR
• Patient Sex: Female
• Patient Weight: 17 KG