MASK PFR95 FS SMALL

Description of Event or Problem

THE HOSPITAL STATED THEY HAD A LARGE AMOUNT OF COMPLAINTS WHERE THE SMALL DUCKBILL N95 MASK ARE BREAKING VERY EASILY. UPON DONNING THE MASKS THE STRAPS WERE PULLING OUT OF THE MASK WHILE IN THE ROOM WITH COVID PATIENTS. 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.

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE FOR RETURN. PREVENTIVE ACTIONS HAVE BEEN IMPLEMENTED. ADDITIONAL HEAD STRAP MATERIAL WAS ADDED TO RESPIRATORS FOR A LONGER ELONGATION. A QUALITY ALERT WAS POSTED FOR TEAMMATES TO CAREFULLY REVIEW THE CORRECT HEAD STRAP POSITION FOR RESPIRATORS. THERE WAS NO LOT NUMBER PROVIDED BY THE REPORTER, THEREFORE, NO DHR RECORD REVIEW WAS POSSIBLE TO DETERMINE IF ANYTHING HAPPENED DURING MANUFACTURE THAT COULD POSSIBLY CONTRIBUTE TO THE ISSUE. ROOT CAUSE WAS NOT IDENTIFIED. 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.