PFR P2 FILTERING RESPIRATOR YELLOW 50

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THIS COMPLAINT IS NOT AVAILABLE. 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.

Description of Event or Problem

THE CLINICIAN REPORTED THAT A MEMBER OF THE NURSING STAFF WAS WEARING A MASK IN A QUARANTINE AREA FOR CONTAGIOUS DISEASES (COVID). THE BLUE ELASTIC BAND HOLDING THE MASK TO THE WEARER'S FACE SUDDENLY BROKE. THE NURSING STAFF LEFT THE TREATMENT AREA TO RE-MASK.

Additional Manufacturer Narrative

ACCORDING TO THE DEVICE HISTORY RECORDS, THE PRODUCT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES AND LOT WAS RELEASED BY QUALITY ASSURANCE. A QUALITY NONCONFORMANCE WAS NOT REPORTED AT THE TIME OF PRODUCTION. THE OPERATOR DOCUMENTED A CHANGE ON THE MACHINE SEALER DUE TO FAILURES IN SEAL OF THE ELASTIC. MANUFACTURING CONDUCTS VISUAL AND FUNCTIONAL INSPECTIONS THROUGHOUT PRODUCTION. A SAMPLING PLAN ANSI/ASQZ 1.4 IS USED TO RELEASE PRODUCT. FUNCTIONAL INSPECTION IS PERFORMED BASED ON AQL 0.65 LEVEL S-4 TO ASSURE COMPLIANCE TO APPLICABLE REQUIREMENTS. A SAMPLE EVALUATION WAS NOT CONDUCTED; HOWEVER, BASED ON THE PHOTOGRAPHS PROVIDED, THE CUSTOMER COMPLAINT ISSUE IS CONFIRMED. COMPLAINTS WERE ANALYZED THROUGH STATISTICAL ANALYSIS TOOL FOR THE PAST 12 MONTHS FROM NOVEMBER 2023 TO NOVEMBER 2024; THERE IS NO UPWARD TREND FOR THIS ISSUE. THE PREVIOUS DUCKBILL BONDING PROCESS USED A HERRMANN ULTRASONICS SYSTEM, THE SPACE BETWEEN THE HORN AND THE ANVIL IS CONTROLLED BY THE SYSTEM. THE DUCKBILL BONDING PROCESS ON THE HERRMANN ULTRASONICS SYSTEM WAS CHANGED TO IMPROVE THE DUCKBILL BONDING PROCESS TO HAVE A MORE CONSISTENT BOND. THE NEW METHOD SYSTEM CONTROLS THE FORCE APPLIED BETWEEN THE HORN AND THE ANVIL; THE POSITION MAY VARY DEPENDING ON THIS FORCE APPLIED. THE CHANGE WAS IMPLEMENTED AFTER THE COMPLAINT PRODUCT WAS MANUFACTURED. NOTIFICATION WAS SENT TO MANUFACTURING LEADERS 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.