MASK PFR95 FS SMALL

Additional Manufacturer Narrative

THREE (3) SAMPLES ARRIVED WITH DETACHED ELASTIC HEADBANDS. THERE IS NO DAMAGE OBSERVED ON ANY OF THE BLUE ELASTIC BOND POINTS. THE DETACHMENT APPEARS TO COME FROM THE SEPARATION OF THE CORNER BOND AREAS. TWELVE (12) RANDOM SAMPLES FROM THE DIFFERENT BOXES WERE OPENED AND THE ELASTIC HEAD BANDS WERE TUGGED AS IF FOR DONNING.THE ELASTIC HEAD BANDS OF FIVE (5) OF THESE SAMPLES DETACHED FROM ONE OF THE CORNER BONDS. THERE IS NO DAMAGE OBSERVED ON ANY OF THE BLUE ELASTIC BOND POINTS. THE DETACHMENT APPEARS TO COME FROM THE SEPARATION OF THE CORNER BOND AREAS. THE OTHER SEVEN (7) SAMPLES EXHIBIT PARTIAL SEPARATION AT THE CORNER BOND AREAS AND THE APPEARANCE OF THE ONSET OF DETACHING ELASTIC HEAD BANDS. A REVIEW OF DHR PRODUCTION RECORDS WAS COMPLETED. PULL STRENGTH HEADSTRAP TESTS ARE CONDUCTED PER SPECIFICATION. THE RECORDS FROM THIS LOT SHOW AN AVERAGE OF 6.LBS (WITHIN SPECIFICATION). DOCUMENTED RECORDS SHOW ALL VISUAL AND FUNCTIONAL INSPECTIONS WERE WITHIN SPECIFICATIONS AND THERE WERE NO NONCONFORMANCES DOCUMENTED DURING PRODUCTION OF THE COMPLAINT LOT. 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, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

Description of Event or Problem

THE CUSTOMER STATED, WE HAVE SEVEN DUCKBILL STRAPS BREAK. THE RN REPORTED THAT ONE BROKE WHILE IN COVID ROOM. MOST BROKE THE FIRST TIME THEY WERE BEING DONNED. THEN ONE BROKE AFTER BEING IN AN ISOLATION ROOM. 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. PLEASE NOTE THAT IN THIS INCIDENT, THE REPORTER HAS INDICATED THAT NO INJURY OR ILLNESS RESULTED.