PFR95 PART FILT RESP

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. A SAMPLE OR LOT NUMBER WAS NOT PROVIDED; THEREFORE NO DEVICE HISTORY RECORD (DHR) REVIEW WAS POSSIBLE. NO SAMPLE EVALUATION WAS CONDUCTED. A ROOT CAUSE WAS NOT DETERMINED. A QUALITY NON CONFORMANCE WAS OPENED TO INVESTIGATE POSSIBLE ROOT CAUSE OF DAMAGE, AND TO IDENTIFY ANY PREVENTIVE AND CORRECTIVE ACTIONS TO BE TAKEN. COMPLAINT TREND WAS REVIEWED FOR PRODUCT CODE 46727 FAILURE MODE AND IT DOES SHOW AN UPWARD TREND. NOTIFICATION WAS SENT TO MANUFACTURING LEADERS FOR AWARENESS. QUALITY ALERTS WERE POSTED IN MANUFACTURING PROVIDING VISUAL INSTRUCTIONS DETAILING THE CORRECT HEAD STRAP POSITION ON RESPIRATOR. ALSO ALERTS HAVE BEEN POSTED FOR PULL TEST LIMIT FOR SEALER ADJUSTMENTS. 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

MASK STRAPS BREAK WHILE ATTEMPTING TO WEAR. THE N95 MASK IS USED FOR COVID 19 PATIENTS. THE MASKS ARE BREAKING 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.