MASK PFR95 FS SMALL

Description of Event or Problem

A STAFF MEMBER/CAREGIVER WAS EXPOSED TO A PATIENT UNDER OBSERVATION WHEN THE HEADBANDS ON THE MASK BROKE. ONE RN EXPERIENCED THE MASK BAND BREAKING WHILE SHE WAS IN THE 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. PLEASE NOTE THAT IN THIS INCIDENT, THE REPORTER HAS INDICATED THAT NO INJURY OR ILLNESS RESULTED.

Additional Manufacturer Narrative

SEVEN (7) RANDOM SAMPLES WERE OPENED AND THE ELASTIC HEAD BANDS WERE GIVEN A MODERATE TUG AS IF FOR DONNING. NONE OF THE ELASTIC HEAD BANDS BROKE OR DETACHED FROM THE CORNER BONDS. THE ELASTIC REMAINED SECURELY ATTACHED INSIDE THE CORNER BONDS AND THE CORNER BONDS REMAINED BONDED TOGETHER. TEN (10) SAMPLES INSIDE THE BOX ARRIVED WITH ONE OR BOTH ELASTIC HEAD BANDS DETACHED FROM ONE OR BOTH OF THE CORNER BONDS. THERE IS NO DAMAGE OBSERVED ON ANY OF THE BLUE ELASTIC BOND POINTS. THE DETACHMENT APPEARS TO COME FROM THE SEPARATION OF THE CORNER BOND AREAS. SIX (6) ADDITIONAL RANDOM SAMPLES WERE OPENED AND THE ELASTIC HEAD BANDS WERE GIVEN A MODERATE TUG AS IF FOR DONNING. THREE (3) OF THESE SAMPLES WERE AFFECTED AND THE ELASTIC DETACHED, IN THIS INSTANCE FROM THE RIGHT SIDE (AS WORN) OF THE CORNER BONDS. THERE IS NO DAMAGE OBSERVED ON ANY OF THE BLUE ELASTIC BOND POINTS. THE DETACHMENT APPEARS TO COME FROM THE SEPARATION OF THE CORNER BOND AREAS. 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 7.2LBS (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.