MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. AMT MINIONE EXTENSION SET; ENTERAL EXTENSION SET

Model Number	8-1255-ISOSAF
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Per the original reporter in uf#: (b)(4), it was reported that, "at the hub where you screw syringes into for a g-tube and middle piece had broken off and was missing not allowing the cover to secure to tube".
Additional Manufacturer Narrative
This report is a response to medsun report#: (b)(4) which was received by amt from the fda on 03/11/2025.The occurrence was originally reported to amt on 02/10/2025 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.Amt worked with the original reporter to obtain the device for examination and performed an inspection of the device once returned.Examination of the device was able to confirm the reported complaint that the adapter cracked.The reported lot number: 241418-004, does not exist.A review of device lots and sales orders found that lot: 241218-004 was most likely the lot that was supposed to be reported with the device failure.A dhr review found that no other similar complaints have been reported for the same manufacturing batch.Recent trending data shows no anomalies in reported failures from the field.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 MINIONE EXTENSION SET
• Common Device Name: ENTERAL EXTENSION SET
• 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 smith ; 8006 katherine boulevard; brecksville, OH 44141 ; 4402622539
• MDR Report Key: 21699693
• Report Number: 1526012-2025-00004
• Device Sequence Number: 15619267
• Product Code: PIF
• UDI-Device Identifier: 00842071132446
• UDI-Public: 00842071132446
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 03/26/2025

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
• Device Model Number: 8-1255-ISOSAF
• Device Catalogue Number: 8-1255-ISOSAF
• Device Lot Number: 241218-004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 7 MO
• Patient Sex: Male