MAUDE Adverse Event Report: NEOTECH PRODUCTS LLC NEOBAR

Model Number	N714
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned, and no testing was possible on the actual device.However, retained samples from several lot numbers (including the same lot number) were re-inspected, and no abnormalities were found.The presence of adhesive, the condition of the medical-grade hydrocolloid adhesive, and its ability to stick to skin were verified.In addition, the device history records (dhr) of the same lot number and the current inventory were reviewed, and no nonconformities were found.Samples of finished goods were selected from the retained samples of the same lot number and the current lot number for re-inspection, and no abnormalities were found.The presence of adhesive was verified, and individual tabs from the retained samples were also inspected.The condition of the medical-grade hydrocolloid adhesive and its ability to stick to skin were confirmed.Based on the clinical information provided and the test results, we were unable to reproduce the issue with any of the samples or confirm the cause of the incident, as all previous and current samples of the product functioned as expected.Per complaint ratio calculation, this incident seems rare to happen.This complaint will be monitored for trending purposes and has been added to the relevant logs and charts.
Event or Problem Description
Separation of one side of the device from patients face and unplanned extubation.

• Brand Name: NEOBAR
• Common Device Name: NEOBAR
• Manufacturer (Section D): NEOTECH PRODUCTS LLC; 28430 witherspoon parkway; valencia CA 91355
• Manufacturer (Section G): NEOTECH PRODUCTS LLC; 28430 witherspoon parkway; valencia CA 91355
• Manufacturer Contact: ben mahajan ; 28430 witherspoon parkway; valencia, CA 91355 ; 6617757466
• MDR Report Key: 24436266
• Report Number: 2025917-2026-00001
• Device Sequence Number: 10227143
• Product Code: CBH
• UDI-Device Identifier: 10812594011129
• UDI-Public: 10812594011129
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 02/24/2026

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: Health Professional
• Device Model Number: N714
• Device Catalogue Number: N714
• Device Lot Number: 2025-0404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown