MASK PFR95 FS SMALL

Additional Manufacturer Narrative

THE FALURE ANALYSIS LAB RECEIVED ONE (1) DISPENSER BOX OF UNUSED SAMPLES. A TOTAL OF THIRTY FIVE (35) SAMPLES WERE RECEIVED. THE ORIGINAL COUNT ON THE DISPENSER BOX IS THIRTY FIVE (35). PRODUCT PACKAGING WAS RECEIVED. THE SAMPLES WERE EVALUATED UNDER AMBIENT LIGHT CONDITIONS. THE SAMPLES WERE REMOVED AND LAID OUT ON THE LAB TABLE FOR INSPECTION. THE SAMPLES APPEAR INTACT. THE ELASTIC HEAD BAND OF SEVEN (7) RANDOM SAMPLES WERE TUGGED AS IF FOR DONNING. NONE OF THE ELASTIC HEAD BANDS BROKE OR DETACHED FROM THE CORNER BONDS, HOWEVER THE CORNER BONDS OF TWO SAMPLES SEPARATED SLIGHTLY ON THE RIGHT SIDE (AS WORN). THE CORNER BOND OF FOUR (4) ADDITIONAL SAMPLES WERE INSPECTED. WITH LITTLE EFFORT THE CORNER BONDS OF ALL FOUR SAMPLES SEPARATED, SOME MORE THAN OTHERS, ON THE RIGHT SIDE (AS WORN). THE ELASTIC OF THE FOUR SAMPLES REMAINED BONDED, HOWEVER BECAUSE THE CORNER BONDS SEPARATED WITH EASE, THE DISPOSITION WILL BE CONFIRMED. THE DEVICE HISTORY RECORDS (DHR) EVALUATION WAS PERFORMED FOR THE CODE 46827 AND LOT NUMBER AM1318811 IDENTIFIED IN THE COMPLAINT. ACCORDING TO THE DOCUMENTED RECORDS, THE PRODUCT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES AND SPECIFICATIONS. THE PRODUCT WAS RELEASED BY QUALITY ASSURANCE. A QUALITY NONCONFORMANCE WAS NOT REPORTED AT THE TIME OF PRODUCTION. MANUFACTURING CONDUCTS VISUAL AND FUNCTIONAL INSPECTIONS OF EACH DEVICE THROUGHOUT PRODUCTION ASIDE FROM THE QA INSPECTION. THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATION REQUIREMENTS. AS A RESULT OF THE INVESTIGATION, IT WAS CONCLUDED THAT THE MOST PROBABLE ROOT CAUSE WAS AN ADJUSTMENT OF THE SEALER BY THE OPERATOR, WHICH CAUSED A LACK OF SEAL IN THE MASK. 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 UTILIZES THE MASKS WHEN SEEING WALK-IN PATIENTS WITH RESPIRATORY SYMPTOMS AND TO PERFORM COVID TESTS. THE CUSTOMER REPORTED THE HEADBAND BREAKING OFF. NORMALLY WEARS ONE MASK A DAY BUT WITH THIS ONE MASK IT WAS REPLACED THREE TIMES A DAY. 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.