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Description of Event or Problem

STRAPS BREAKING PRIOR TO USE. ONE OCCURENCE HAPPENED WHILE STAFF WAS PERFORMING DUTIES IN PATIENT'S ROOM. 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.

Additional Manufacturer Narrative

ONE (1) USED SAMPLE RECEIVED WITH NO PRODUCT PACKAGING. THERE IS A HANDWRITTEN LOT NUMBER ON THE BOTTOM OF THE MASK WHICH MATCHES THE LOT NUMBER REPORTED. THE SAMPLE WAS EVALUATED UNDER AMBIENT LIGHT CONDITIONS. THE SAMPLE ARRIVED WITH THE BLUE ELASTIC HEADBAND COMPLETELY DETACHED FROM BOTH CORNER BOND AREAS. THE BOND POINTS ON EITHER SIDE OF THE ELASTIC HEAD BANDS IS NOT DAMAGED. INSTEAD THERE IS COMPLETE SEPARATION OF BOTH CORNER BONDS OF THE MASK. THE DEVICE HISTORY RECORDS (DHR) EVALUATION WAS PERFORMED FOR THE PRODUCT CODE 46827 IDENTIFIED IN THE COMPLAINT. ACCORDING TO THE DOCUMENTED RECORDS, THE PRODUCT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES AND SPECIFICATIONS. THE PRODUCT WAS RELEASED BY QUALITY ASSURANCE. NO ROOT CAUSE WAS IDENTIFIED. ADDITIONAL HEAD STRAP MATERIAL WAS ADDED TO RESPIRATOR FOR A LONGER ELONGATION. QUALITY ALERTS POSTED IN MANUFACTURING TO REVIEW CORRECT HEAD STRAP POSITION ON RESPIRATOR. MANUFACTURING CONDUCTS VISUAL AND FUNCTIONAL INSPECTIONS THROUGHOUT PRODUCTION ASIDE FROM THE QA INSPECTION. 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.