MASK PFR95 FS SMALL

Additional Manufacturer Narrative

RETURNED SAMPLES WERE EVALUATED UNDER AMBIENT LIGHT CONDITIONS. ONE SAMPLE ARRIVED WITH THE LEFT SIDE UNBONDED. THERE WERE NO TEARS, CUTS OR HOLES ON ANY OF THE SAMPLES, JUST THE ONE UNBONDED SIDE. A POTENTIAL ROOT CAUSE COULD HAVE OCCURRED DURING MACHINE ADJUSTMENTS. 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.

Description of Event or Problem

THE MASKS EXHIBITED THE FOLLOWING ISSUES; MISSING HEADBANDS, HEADBANDS BREAKING/DETACHING, HOLE IN THE MASK MATERIAL, MASK DUCKBILL PORTION SEPARATING/NOT SEALED, INNER LAYERS COMES APART. THE CUSTOMER STATED A CLINICIAN IN THE EMERGENCY ROOM WAS WORKING WITH A PATIENT AND NOTICED A HOLE IN THE MASK. THE CLINICIAN WAS CONCERNED ABOUT EXPOSURE TO COVID-19. THE CLINICIAN DID NOT REPORT ANY INJURY, TESTING PERFORMED, SYMPTOMS, OR OTHER MEDICAL INTERVENTION PERFORMED. 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.