MAUDE Adverse Event Report: NEOTECH PRODUCTS LLC NEOTECH PRODUCTS; NEOSEAL

Model Number	N420
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Cough (4457)
Date of Event	07/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A 42 week infant who was admitted to nicu following birth needing respiratory support via nasal cannula.Neotech foam barrier in place.Infant found to be desaturating and choking on foam barrier.Once rn removed foam barrier infant recovered immediately.Foam barriers removed from unit.
Additional Manufacturer Narrative
This is our response to the report sent to us by fda and filed by (b)(6) hospital - (b)(6).(report number: mw5120017).The actual device was not returned, and no test was possible on the actual device.However, retained samples of the same lot number were re-inspected and no abnormality was found.The presence of adhesive was verified and the condition of adhesive and its ability of sticking to device was verified.In addition, the product's device history records (dhr) of the current inventory were reviewed and no nonconformity was found.Samples of finished goods were pulled out from retained samples of the current lot number for re-inspection and no abnormality was found.The presence of adhesive was verified and the condition of adhesive and its ability of sticking to the device was verified as well.Within the "instruction for use" of the device, neotech clearly mentioned the followings: · step 3 insert prongs per hospital protocol.Document placement of the neoseal in the patient's medical record.· note: to minimize risk of aspiration/ingestion, ensure the nasal cannula prongs and/or neoseal do not enter the infant's mouth.· step 4 replace neoseal daily or per hospital protocol, whichever is sooner.· note: replace immediately if soiled or wet.· step 5 document removal and/or replacement in the patient's medical record.· cautions & warnings.· federal law restricts this device to sale by or on the order of a physician.· choking hazard.Neoseal should only be used while the patient is under the continuous, direct supervision of trained healthcare professionals.· risk of ingestion or aspiration.When in use, ensure the nasal cannula prongs and/or neoseal do not enter the infant's mouth.· replace immediately if soiled or wet.It seems the instructions for use was not followed properly.Neotech has decided to improve the effectiveness of cautions & warnings by printing the chocking hazard on the liners of actual devices.Based on the complaint ratio, the incident appears to be isolated and of very rare occurrence.This complaint will be monitored for trending purposes and is added to the related logs and charts.

• Brand Name: NEOTECH PRODUCTS
• Common Device Name: NEOSEAL
• Manufacturer (Section D): NEOTECH PRODUCTS LLC; 28430 whiterspoon pkwy; valencia CA 91304
• Manufacturer (Section G): NEOTECH PRODUCTS LLC; 28430 whiterspoon parkway; valencia 91355
• Manufacturer Contact: ben mahajan ; 28430 whiterspoon parkway; valencia 91355 ; 6617757464
• MDR Report Key: 17575314
• Report Number: 2025917-2023-00002
• Device Sequence Number: 8222755
• Product Code: BXJ
• UDI-Device Identifier: 10812594012164
• UDI-Public: 10812594012164
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: N/AN/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2024
• Device Model Number: N420
• Device Lot Number: 2022-0101
• 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: 07/20/2023
• Initial Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Life Threatening
• Patient Age: 42 WK
• Patient Sex: Unknown