PFR95 PART. FILTR MASK SM 35

Additional Manufacturer Narrative

THE PRODUCT IN THIS COMPLAINT WAS NOT RETURNED. THE DEVICE HISTORY RECORDS (DHR) EVALUATION WAS PERFORMED FOR PRODUCT CODE 46867 IDENTIFIED IN THIS COMPLAINT. 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. ACCORDING TO DHR REVIEW, 80 SAMPLES WERE EVALUATED DURING PRODUCTION PER HEAD BAND PULL STRENGTH. NO SEALANT ISSUES WERE REPORTED. MANUFACTURING CONDUCTS VISUAL AND FUNCTIONAL INSPECTIONS THROUGHOUT PRODUCTION ASIDE FROM THE QA INSPECTION. THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATION REQUIREMENTS. THIS COMPLAINT LOT WAS EXPIRED. 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. H3 : DEVICE NOT RETURNED.

Description of Event or Problem

"WE HAD AN ISSUE WHERE 4 MASKS FROM A BOX OF ITEM 46867 HAD BROKEN STRAPS. THE MASK BROKE IN OUR CICU/ED DEPARTMENTS." NO INJURY WAS REPORTED DURING MASK USE. THE INCIDENT WAS REPORTED TO EMPLOYEE HEALTH AND NURSING SUPERVISOR. 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.