MASK PFR95 FS SS REG

Description of Event or Problem

THE STRAPS ARE BREAKING ON MULTIPLE LOTS 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.

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION. ACCORDING TO DEVICE HISTORY RECORD (DHR), THE COMPLAINT LOT IS OVER 14 YEARS OLD. PRODUCT CODE 46727 HAS A SHELF-LIFE OF 5 YEARS. ACCORDING TO LOT NUMBER PROVIDED, THE PRODUCT HAD EXPIRED. 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, AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.