MASK PFR95 FS SMALL

Additional Manufacturer Narrative

ONE (1) UNUSED SAMPLE RECEIVED WITH NO PRODUCT PACKAGING. THE SAMPLE WAS EVALUATED UNDER AMBIENT LIGHT CONDITIONS. THE SAMPLE WAS COMPARED TO SPECIFICATION COMPONENT. THE INNER LAYER OF MATERIAL OF THE TOP PORTION OF THE MASK IS NOT ATTACHED. THE DEVICE HISTORY RECORDS (DHR) EVALUATION WAS PERFORMED FOR PRODUCT CODE 46827 IDENTIFIED IN THE COMPLAINT. ACCORDING TO THE DOCUMENTED RECORDS, THE PRODUCT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES AND SPECIFICATIONS. THE PRODUCT WAS RELEASED BY QUALITY ASSURANCE. A QUALITY NONCONFORMANCE WAS NOT REPORTED AT THE TIME OF PRODUCTION. MANUFACTURING CONDUCTS VISUAL AND FUNCTIONAL INSPECTIONS THROUGHOUT PRODUCTION ASIDE FROM THE QA INSPECTION. A POTENTIAL ROOT CAUSE IS A MATERIAL ADJUSTMENT FIXTURE OF THE MACHINE. THIS COULD HAVE CAUSE MATERIAL INSIDE TO NOT SEAL CORRECTLY TO RESPIRATOR. 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, AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

Description of Event or Problem

INNER LINING OF MASK NOT ATTACHED AT SEAM ON ONE SIDE OF MASK. THE INCIDENT WAS REPORTED TO HAVE OCCURRED DURING USE. THE FOLLOWING MEDICAL DEVICE REPORT IS BEING FILED RETROACTIVE TO PRIOR DECISION THAT THIS MALFUNCTION WOULD BE UNLIKELY TO RESULT IN A SERIOUS INJURY OR ILLNESS. A REASSESSMENT OF THIS INCIDENT HAS SINCE FOUND THAT SHOULD THIS MALFUNCTION RECUR IN AN ISOLATION SETTING OR DURING DIRECT PATIENT CARE, THE END USER MAY CONTRACT COVID VIRUS AND THUS BE SUSCEPTIBLE TO A SERIOUS ILLNESS. FOR THIS REASON THIS INCIDENT IS BEING REPORTED AS A MALFUNCTION AT THIS TIME.