MASK PFR95 FS SMALL

Additional Manufacturer Narrative

A TOTAL OF TWENTY EIGHT (28) SAMPLES AND ONE (1) DISPENSER BOX WAS RECEIVED. THE SAMPLES WERE EVALUATED UNDER AMBIENT LIGHT CONDITIONS. THE SAMPLES ARRIVED INSIDE A CRUSHED DISPENSER BOX. TWO (2) SAMPLES ARRIVED WITH DETACHED HEAD BANDS FROM THE LEFT (AS WORN) SIDE. THE BOND POINTS OF THE ELASTIC ARE NOT DAMAGED. THE CORNER BONDS OF EACH MASK APPEAR SEPARATED. THE REMAINING SAMPLES WERE INSPECTED. THE ELASTIC OF EIGHT (8) RANDOM SAMPLES WERE TUGGED AS IF FOR DONNING. TWO HEADBANDS DETACHED. ONE TORE AND THE OTHER ONE DETACHED FROM A SEPARATED CORNER BOND. THE CORNER BOND FROM SOME OF THE OTHER SAMPLES STARTED TO SEPARATE BUT DID NOT COMPLETELY SEPARATE. THE DEVICE HISTORY RECORDS (DHR) EVALUATION WAS PERFORMED FOR THE PRODUCT CODE 46827 IDENTIFIED IN THE COMPLAINT. ACCORDING TO THE DOCUMENTED RECORDS, THE PRODUCT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES AND SPECIFICATIONS THEN RELEASED BY QUALITY ASSURANCE. A QUALITY NONCONFORMANCE WAS NOT REPORTED AT THE TIME OF PRODUCTION. ROOT CAUSE WAS INCORRECT SETUP. 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 ELASTIC STRAPS SEEM TO BE FAULTY WITHIN THE MASK AS THEY KEPT SNAPPING. MULTIPLE MASKS WERE TRIED TO NO AVAIL. THE PRODUCT 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. THE REPORTER HAS INDICATED THAT NO INJURY OR ILLNESS RESULTED.