MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. AMT MINI ONE EXTENSION SET; 24" MINI ONE® RIGHT ANGLE FEEDING SET WITH DUAL ENFIT ® Y-PORT

Model Number	8-2455-ISOSAF
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is in response to mw5155637 which was received by amt from the fda on 06/24/2024.Based on the provided information, the reported 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-threatenin0g, nor did this result in permanent impairment or necessitate medical or surgical intervention to preclude permanent impairment.Amt reached out to the reporter in attempts to retrieve the device for examination.At the time of this report there has been no response to the availability of the device.Due to this, a visual and functional evaluation could not be performed, and device failure could not be confirmed.Based on the provided information, the reported complaint is not believed to have been caused by a manufacturing defect.A complaint has been logged in our system to track this record in complaint #: (b)(4) and will be used for trend analysis.
Event or Problem Description
It was reported that the "medicine port cap of the enteral feeding extension set will occasionally come loose, resulting in the loss of enteral feed, and the emptying of gastric contents.This does not occur with the design of the competitors product that we switched from.The mic-key extension sets have caps that screw closed with threads, whereas the mini one caps use friction alone".

• Brand Name: AMT MINI ONE EXTENSION SET
• Common Device Name: 24" MINI ONE® 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 smith ; 8006 katherine boulevard; brecksville 44141 ; 4402622539
• MDR Report Key: 19766554
• Report Number: 1526012-2024-00009
• Device Sequence Number: 21013895
• Product Code: PIF
• UDI-Device Identifier: 00842071107864
• UDI-Public: 00842071107864
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2024

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?: No
• Operator of Device: Other
• Device Model Number: 8-2455-ISOSAF
• Device Catalogue Number: 8-2455-ISOSAF
• Device Lot Number: 231211-210
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 07/17/2024
• 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: 12 MO
• Patient Sex: Male
• Patient Weight: 8 KG