PFR95 PART. FILTR MASK SM 35

Additional Manufacturer Narrative

TWO (2) USED SAMPLES WERE RECEIVED WITH NO PRODUCT PACKAGING. THE SAMPLES WERE EVALUATED UNDER AMBIENT LIGHT CONDITIONS. BOTH SAMPLES ARRIVED WITH THE ELASTIC HEAD STRAP DETACHED FROM THE RIGHT SIDE (AS WORN). SAMPLE ONE HAS A PARTIALLY DETACHED ELASTIC HEAD BAND. THERE IS A SMALL PIECE OF THE ELASTIC HEAD BAND STILL ATTACHED IN BETWEEN THE TWO LAYERS AT THE CORNER BOND AREA. SAMPLE TWO EXHIBITS A COMPLETELY DETACHED ELASTIC HEAD BAND. THE BLUE ELASTIC IS NOT DAMAGED WHERE IT WOULD BE BONDED INSIDE THE CORNER OF THE MASK. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORD EVALUATION COULD NOT BE PREFORMED. 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

STAFF HAVE NOTIED BROKEN STRAPS WITH THE N95 MASKS. THE REPORTER INDICATED, "I ALSO WATCHED A NURSE GO TO PUT HERS ON AND THE MASK STRAP BROKE WITH REALLY NO TENSION." THE REPORTER INDICATES INCIDENT 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.