MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. AMT BRIDLE PRO; NASAL TUBE RETAINING SYSTEM

Model Number	E4-420810
Medical Device Problem Codes	Detachment of Device or Device Component (2907); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is in response to medsun uf report # (b)(4) which was received by amt from the fda on 06/16/2025.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-threatening, 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 on (b)(6) 2025.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
Per the original reporter in uf report #:(b)(4), it was reported that, "while trying to bridle the pt.'s duotube, it was discovered that one of the magnets fell off the end when trying to remove and reposition the stylets.The magnet was connected to the opposite stylet upon removal".

• Brand Name: AMT BRIDLE PRO
• Common Device Name: NASAL TUBE RETAINING SYSTEM
• 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: 22497240
• Report Number: 1526012-2025-00011
• Device Sequence Number: 7028839
• Product Code: KNT
• UDI-Device Identifier: 00842071115876
• UDI-Public: 00842071115876
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K142971
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/14/2025

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: Health Professional
• Device Model Number: E4-420810
• Device Catalogue Number: E4-420810, 4-420810
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 07/14/2025
• 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: 49 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White