PFR95 PART FILT RESP

Additional Manufacturer Narrative

FIVE (5) RANDOM SAMPLES WERE INSPECTED. THE MASKS WERE OPENED AND THE ELASTIC HEAD BANDS WERE TUGGED WITH MODERATE FORCE. 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. A REVIEW OF DHR PRODUCTION RECORDS WAS COMPLETED. 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.

Description of Event or Problem

THE DISTRIBUTOR REPORTED THAT DEFECTIVE HEADBANDS TEAR 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 OR PATIENT MAY BE AT AN INCREASED RISK OF CONTRACTING A PATHOGEN. 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.