MAUDE Adverse Event Report: O&M HALYARD, INC. HALYARD FLUIDSHIELD 3 N95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK; ICP FACIAL PROTECTION PRODUCTS

Model Number	46727
Medical Device Problem Codes	Component Incompatible (1108); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) had a tb outbreak.The (b)(6) osh unit collaborated with (b)(6) and performed n95 fit testing using quantitative test method following the osha fit test protocol.Staff wearing the product while performing the test failed.At this time, it is unclear whether the hospital performed fit testing prior to the reported outbreak or what quantity of end-users were affected by tb.
Additional Manufacturer Narrative
The product involved in this complaint is not available for evaluation.A follow-up report will be provided upon conclusion of the investigation.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a o&m halyard, inc.Product is defective or has caused serious injury.
Additional Manufacturer Narrative
Additional incident questions were asked to the end-user.On april 28, 2025, the end-user provided information that five employees from hospital (b)(6) emergency department had contracted tb during time period (b)(6) 2025.These employees were all treated for tb and have since moved from intensive treatment to maintenance (further details of treatment were not provided).According to hospital, they do not fit test all wearers prior to use.They only fit test a certain quantity of workers.They were unable to share whether these particular employees were fit tested utilizing the halyard code prior to contracting tb.There is a precaution on the product labeling advising end-users to perform fit testing.The hospital utilizes both the halyard mask product reported in this device report as well as a 3m mask.According to the hospital, the employees wear whichever is available at the time of need.A follow-up report will be provided upon conclusion of the investigation.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a o&m halyard, inc.Product is defective or has caused serious injury.
Additional Manufacturer Narrative
Incident one: the product involved in this complaint is not available for evaluation.A device history records (dhr) evaluation was performed for the complaint lot.According to the documented records, the product was manufactured according to approved manufacturing procedures, specifications and released by quality assurance.Manufacturing conducts visual and functional inspections throughout production.Inspection sampling plan ansi/asqz 1.4 is utilized to release the product.Visual inspection is performed based on aql 0.65 level s-4 to assure compliance to specification.Complaint history for the past 12 months from (b)(6) 2024 to (b)(6) 2025 shows no upward trend for related issue.Complaint notification was sent to manufacturing leaders for awareness.Root cause was defined as user error, the end-user failed to perform fit testing on all users prior to mask wear.The purpose of fit testing is to ensure the product properly conforms to the user's face to provide sufficient user protection.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a o&m halyard, inc.Product is defective or has caused serious injury.

• Brand Name: HALYARD FLUIDSHIELD 3 N95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK
• Common Device Name: ICP FACIAL PROTECTION PRODUCTS
• Manufacturer (Section D): O&M HALYARD, INC.; 1220 old alpharetta rd; ste 320; alpharetta GA 30005
• Manufacturer (Section G): LA ADA DE ACUNA; km 4.5 carreterra presa la amistad; ciudad de acuna; coahuila, mexico
• Manufacturer Contact: nichole coggins ; 1220 old alpharetta rd; ste 320; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 21753541
• Report Number: 9616096-2025-00002
• Device Sequence Number: 8220725
• Product Code: MSH
• UDI-Device Identifier: 20680651467274
• UDI-Public: 20680651467274
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K974068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2025

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 Model Number: 46727
• Device Catalogue Number: 46727
• Device Lot Number: AM1259801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 04/28/2025; 05/23/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 05/22/2025; 05/28/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown