HALYARD FLUIDSHIELD 3 N95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK

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.

Description of Event or Problem

(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.