HALYARD PFR P2 FILTERING HALF MASK YELLOW

Description of Event or Problem

MASKS CONTAINED A YELLOW PLASTIC LINER ON THE INSIDE WHICH MADE IT DIFFICULT FOR SOME TEAM MEMBERS TO BREATHE AFTER A FEW MINUTES. COUNTRY HAS HIGH HUMIDITY. SEVERAL MISSION TEAM MEMBERS REPORTED DIFFICULTIES BREATHING WHILE WEARING THE MASKS. SOME EXPERIENCED PANIC ATTACKS AND HAD TO LEAVE RED ZONE QUICKLY, WITHOUT FOLLOWING FULL EBOLA PROCEDURES. TEAM WAS WORKING IN EBOLA TREATMENT CENTER ON MISSION. ADDITIONAL INFORMATION FROM REPORTER IS PENDING.

Additional Manufacturer Narrative

INCIDENT ONE. THE PRODUCT INVOLVED IN THIS COMPLAINT IS SAID TO BE AVAILABLE FOR EVALUATION BUT HAS NOT BEEN RECEIVED. 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

A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) FOR THE PRODUCT IDENTIFIED IN THE COMPLAINT WAS CONDUCTED AND CONFIRMED THAT THE PRODUCT WAS MANUFACTURED IN ACCORDANCE WITH APPROVED MANUFACTURING PROCEDURES AND SPECIFICATIONS AND SUBSEQUENTLY RELEASED BY QUALITY ASSURANCE. NO QUALITY NONCONFORMANCES WERE REPORTED AT THE TIME OF PRODUCTION. THROUGHOUT THE MANUFACTURING PROCESS, ROUTINE VISUAL AND FUNCTIONAL INSPECTIONS WERE PERFORMED BY PRODUCTION PERSONNEL IN ADDITION TO THE FINAL QUALITY ASSURANCE INSPECTION. SAMPLING AND VISUAL INSPECTIONS WERE CONDUCTED IN ACCORDANCE WITH AN AQL OF 0.65, LEVEL S-4, TO ENSURE COMPLIANCE WITH APPLICABLE REQUIREMENTS. THE REVIEW IDENTIFIED NO DOCUMENTED ISSUES OR NONCONFORMITIES DURING MANUFACTURING. AS PART OF THE IN-PROCESS FUNCTIONAL INSPECTION DURING THE LOT RUN, DELTA P (¿P) TESTING WAS PERFORMED TO MEASURE THE PRESSURE DIFFERENTIAL GENERATED WHEN CONTROLLED AIRFLOW PASSES THROUGH THE FILTERING MATERIAL. THIS TEST SERVES AS AN INDICATOR OF MASK BREATHABILITY AND USER COMFORT. MANUFACTURING RESULTS DEMONSTRATED STABLE ¿P VALUES ACROSS ALL MEASUREMENTS, INDICATING MATERIAL UNIFORMITY AND PROCESS CONSISTENCY. NO VALUES EXCEEDED ESTABLISHED ACTION LIMITS, CONFIRMING THAT THE PRODUCT MET ACCEPTANCE CRITERIA. PER PRODUCT SPECIFICATIONS, THE MASK INCLUDES AN INTERNAL CLEAR FILM DESIGNED TO IMPROVE FACIAL FIT AND ENHANCE SEALING PERFORMANCE. WHEN USED AS INTENDED, THE PRODUCT IS EXPECTED TO PROVIDE A WIDE MARGIN OF SAFETY. BASED ON THE AVAILABLE INFORMATION AND INVESTIGATION RESULTS, A ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE IDENTIFIED, AS THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH APPROVED SPECIFICATIONS AND APPLICABLE REGULATORY REQUIREMENTS. A COMPLAINT TREND REVIEW FOR PRODUCT CODE 62408 RELATED TO FOREIGN OBJECT FAILURES OVER THE PAST 12 MONTHS (NOVEMBER 2024 TO NOVEMBER 2025) SHOWED NO UPWARD TREND. MANUFACTURING LEADERSHIP WAS NOTIFIED FOR AWARENESS. 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.