MASK PFR95 FS SMALL

Description of Event or Problem

THE ELASTIC BAND MASK SNAPPED WHILE THE RN WAS RENDERING PATIENT CARE ON A COVID-19 PATIENT. 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. A REVIEW OF DHR PRODUCTION RECORDS WAS COMPLETED. PULL STRENGTH HEADSTRAP TESTS ARE CONDUCTED PER SPECIFICATION REQUIRING 4.0LBS PERFORMANCE STRENGTH. THE RECORDS FROM THIS LOT SHOW AVERAGE OF 7.0LBS (WITHIN SPECIFICATION). DOCUMENTED RECORDS SHOW ALL VISUAL AND FUNCTIONAL INSPECTIONS WERE WITHIN SPECIFICATIONS AND THERE WERE NO NONCONFORMANCES DOCUMENTED DURING PRODUCTION OF THE COMPLAINT LOT. NO ROOT CAUSE WAS 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. H3 OTHER TEXT : DEVICE NOT RETURNED.