MASK PFR95 FS SS REG

Additional Manufacturer Narrative

THE PRODUCT SAMPLE INVOLVED IN THE COMPLAINT WAS NOT AVAILABLE FOR RETURN. THE DEVICE HISTORY RECORDS (DHR) EVALUATION WAS PERFORMED FOR THE CODE 46767 IDENTIFIED IN THE COMPLAINT. ACCORDING TO THE DOCUMENTED RECORDS, THE PRODUCT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS AND RELEASED BY QUALITY ASSURANCE. A QUALITY NON CONFORMANCE WAS NOT REPORTED AT THE TIME OF PRODUCTION. THE ACCEPTANCE CRITERIA ARE GREATER THAN 4 LBS. PULL STRENGTH RESULTS DURING IN-PROCESS TESTING AND FINAL RELEASE TESTING WELL EXCEEDED THE SPECIFICATION REQUIREMENTS. MANUFACTURING CONDUCTS VISUAL AND FUNCTIONAL INSPECTIONS OF EACH DEVICE THROUGHOUT PRODUCTION ASIDE FROM THE QA INSPECTION. THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATION REQUIREMENTS. NO ROOT CAUSE WAS FOUND THROUGHOUT PROCESS. 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 OTHER TEXT : DEVICE NOT RETURNED.

Description of Event or Problem

INCIDENT ONE: THE COVID UNIT AT (B)(6) HOSPITAL, A PART OF THE (B)(6) SYSTEM, HAS BEEN EXPERIENCING PRODUCT ISSUES WITH THE HALYARD N95 MASK 46767. STAFF IS REPORTING THE STRAPS ARE BREAKING WHEN TRYING TO WEAR THE MASKS. THE STAFF ARE GIVEN ONE MASK PER SHIFT BUT SOMETIMES HAVE TO USE TWO-THREE BECAUSE OF BREAKING. 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.