MASK PFR95 FS SS REG

Description of Event or Problem

WE RECEIVED COMPLAINTS ABOUT THE QUALITY OF THE MASK. WHEN HANDLING THE MASK THE ELASTIC BREAKS. THIS INCIDENT OCCURRED IN THE INTENSIVE CARE UNIT AND IT IS VERY CONCERNING. 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.

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORDS (DHR) EVALUATION WAS PERFORMED FOR THE PRODUCT CODE 46767 IDENTIFIED IN THE COMPLAINT. 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. A ROOT CAUSE WAS NOT IDENTIFIED. MANUFACTURING CONDUCTS VISUAL AND FUNCTIONAL INSPECTIONS THROUGHOUT PRODUCTION ASIDE FROM THE QA INSPECTION. THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATION REQUIREMENTS. 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. H3 OTHER TEXT : DEVICE NOT RETURNED.