MASK PFR95

Description of Event or Problem

AN ANESTHESIOLOGIST DR. (B)(6) STATED, " I HAVE BEEN USING YOUR DUCKBILL N-95 MASK AND THEY HAVE BEEN SEPARATING AT ONE OF THE SEAMS. I WAS TAKING CARE OF A COVID POSITIVE PATIENT WHEN I WAS WEARING A MASK THAT OPENED AT THE SEAMS." 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. THE REPORTER HAS INDICATED THAT NO INJURY OR ILLNESS RESULTED.

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. WITHOUT A SAMPLE OR A LOT NUMBER, IT IS NOT POSSIBLE TO ASSESS THE DEVICE HISTORY RECORDS. A ROOT CAUSE WAS NOT DETERMINED. 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. H3 OTHER TEXT : DEVICE NOT RETURNED