HALYARD FLUIDSHIELD N95 PARTICULATE FILTER RESPIRATOR

Description of Event or Problem

THE CLINICIAN REPORTED THE INNER LINING OF THE MASK BECAME WET WITHIN 15 TO 30 MINUTES OF USE AND SUBSEQUENTLY COLLAPSED AGAINST THE NOSE AND MOUTH, MAKING BREATHING MOREDIFFICULT. NO ISSUES WITH MASK TIGHTNESS, LOOSENESS, OR IMPROPER FIT WERE OBSERVED DURING USE. THE MASKS WERE WORN CONTINUOUSLY INSIDE THE HIGH-RISK ZONE OF AN EBOLA TREATMENTCENTER.FOLLOWING USE, THE MASKS WERE REMOVED SAFELY DURING THE PERSONAL PROTECTIVE EQUIPMENT (PPE) DOFFING PROCESS AND IMMEDIATELY DISCARDED. THE CLINICIAN NOTED THAT ALL MASKS WEREWET AFTER USE, WHICH WAS CONSIDERED NORMAL GIVEN THE PROLONGED USE OF FULL PPE IN THE HIGH-RISK ENVIRONMENT. THE PLASTIC REINFORCEMENT PIECES LOCATED ALONG THE UPPER AND LOWERINNER EDGES OF THE MASKS REMAINED INTACT BEFORE AND AFTER USE.

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THIS COMPLAINT IS NOT AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF THE INVESTIGATION.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. PRODUCTIS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.