MASK PFR95 FS SMALL

Additional Manufacturer Narrative

SIX (6) USED SAMPLE WERE RECEIVED. NO PRODUCT PACKAGING WAS RECEIVED. ALL SIX (6) SAMPLES ARE KIMBERLY CLARK BRANDED. THE SAMPLES WERE EVALUATED UNDER AMBIENT LIGHT CONDITIONS. THE SAMPLES WERE INSPECTED. ALL SIX (6) SAMPLES ARRIVED WITH BROKEN HEAD STRAPS. THE ELASTIC HEAD BAND MATERIAL WAS GENTLY MANIPULATED. THE ELASTIC BROKE ON EACH ONE OF THE HEAD STRAPS WHICH WERE STRETCHED. THIS PRODUCT IS OVER 14 YEARS OLD FROM THE LOT PROVIDED. PRODUCT CODE 46827 RECORDED IN THIS COMPLAINT HAS A SHELF LIFE OF 5 YEARS. THEREFORE THIS PRODUCT HAS EXPIRED. NOTIFICATION WAS SENT TO MANUFACTURING LEADERS FOR AWARENESS. 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.

Description of Event or Problem

THE NURSING STAFF INDICATED THAT THE BANDS ON THE N95 MASKS ARE SNAPPING. THE INCIDENT WAS REPORTED TO HAVE OCCURRED DURING USE. 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.