PFR95 PART FILT RESP

Description of Event or Problem

WHILE THE NURSE WAS PROVIDING PATIENT CARE ON A COVID POSITIVE PATIENT, THE STRAPS BROKE AT THE CORNER OF THE MASK. THE CLINICIAN REPORTED NO INJURY, NO SYMPTOMS, NO MEDICAL INTERVENTION OR MEDICAL TESTING OR TREATMENT PERFORMED. THE CUSTOMER REPORTED THAT THIS HAS OCCURRED OVER THE PAST SEVERAL MONTHS AND THE CLINICIANS WERE STAPLING THE STRAPS TO THE MASKS, THEY HAVE SINCE DISCONTINUED THAT PRACTICE. 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

THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE FOR RETURN. THE CONTENT OF THIS ISSUE, THE STRAPS BROKE AT THE CORNER OF THE MASK, WAS FORWARDED TO THE APPROPRIATE FUNCTIONAL AREA FOR INVESTIGATION AND ROOT CAUSE DETERMINATION. BASED ON THE RESULTS OF THE INVESTIGATION, A SAMPLE WAS NOT PROVIDED AND THE PRODUCT COULD NOT BE EVALUATED. A DEVICE HISTORY RECORD EVALUATION WAS PERFORMED FROM THE LOT NUMBER REPORTED WHICH SHOWED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO APPROVED PROCEDURES, SPECIFICATIONS AND THEN RELEASED BY QUALITY ASSURANCE. NOTIFICATION WAS SENT TO MANUFACTURING LEADERS FOR AWARENESS PURPOSES ONLY. WE WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS PRODUCT. A ROOT CAUSE WAS NOT 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. H3 OTHER TEXT : DEVICE NOT RETURNED.