MASK PFR95 FS SMALL

Additional Manufacturer Narrative

ONE (1) UNUSED SAMPLE RECEIVED WITH NO PRODUCT PACKAGING. THE SAMPLE WAS EVALUATED UNDER AMBIENT LIGHT CONDITIONS. THE SAMPLE ARRIVED INTACT. THE SAMPLE WAS OPENED AND THE ELASTIC HEAD BANDS WERE TUGGED WITH MODERATE FORCE. THERE WAS NO SEPARATION OF THE CORNER BONDS AND THERE WAS NO DETACHMENT OF THE ELASTIC HEAD BANDS. 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 AND RELEASED BY QUALITY ASSURANCE. NO ROOT CAUSE WAS IDENTIFIED. THE PULL STRENGTH HEAD STRAP SPECIFICATION REQUIRES EQUAL OR GREATER THAN 4LB RESULTS. THE PULL STRENGTH TEST RESULTS FOR THIS LOT AVERAGE 6LBS. MANUFACTURING CONDUCTS VISUAL AND FUNCTIONAL INSPECTIONS THROUGHOUT PRODUCTION ASIDE FROM THE QA INSPECTION. 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

OUR NURSING LEADER(S) STATED SMALL DUCKBILL MASKS (PRODUCT CODE: 46827) ARE BREAKING. THE MASK ARE TEARING (TWO LAYERS SEPARATED AT CORNERS) WHERE THE MASKS AND ELASTIC JOIN. SOME NURSES WERE STAPLING THE MASKS AT THE CORNERS. IT WAS REPORTED THIS 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.