QUALA SALIVA EJECTOR

Additional Manufacturer Narrative

THE 510(K) NUMBER IN THE INITIAL REPORT SUBMITTED WAS A TYPO AND IS NOT APPLICABLE TO THIS MDR. FOLLOWING THE REPORTED EVENT, PRODUCT RETAINS FROM THE REPORTED LOT WERE EVALUATED. NO ISSUES WERE NOTED; THE REPORTED ISSUE WAS NOT ABLE TO BE CONFIRMED. RETURN PRODUCT WAS RECEIVED FROM THE USER FACILITY ON JULY 7, 2021 AND FOLLOWING EVALUATION, THE REPORTED ISSUE WAS ABLE TO BE CONFIRMED. THE RETURN PRODUCT EVALUATION REPORTED AN ABSENCE OF METHYL ETHYL KETONE (MEK) WHICH IS USED TO WELD THE CAP AND TUBE OF THE SALIVA EJECTOR TOGETHER. THE LIKELY ROOT CAUSE OF THIS ISSUE IS THAT DURING THE INITIAL START-UP OF THE EQUIPMENT, THE OPERATORS DID NOT SCRAP THE FIRST BAG OF SALIVA EJECTORS PRODUCED AS STATED IN THE WORK INSTRUCTION. THE REPORTED EVENT REMAINS AN ISOLATED OCCURRENCE TO THIS LOT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Additional Manufacturer Narrative

A DISTRIBUTOR OF CROSSTEX SALIVA EJECTORS REPORTED THAT AN END USER REPORTED THE SALIVA EJECTOR TIP DETACHED FROM THE SALIVA EJECTOR TUBE DURING A DENTAL PROCEDURE. IT WAS REPORTED THAT THE TIP BECAME LODGED IN THE PATIENT'S AIRWAY. THE TIP WAS NOT SWALLOWED AND WAS ABLE TO BE RETRIEVED AND WAS THROWN AWAY. THE REPORTED EVENT DID NOT CAUSE OR CONTRIBUTE ANY SERIOUS INJURY OR DETERIATION OF HEALTH. THIS EVENT COULD POTENTIALLY LEAD TO SERIOUS INJURY IF IT WERE TO RECUR. CROSSTEX WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS TO ENSURE THE PRODUCT CONTINUES TO PERFORM AS EXPECTED.

Description of Event or Problem

A DISTRIBUTOR OF CROSSTEX SALIVA EJECTORS REPORTED THAT AN END USER REPORTED THE SALIVA EJECTOR TIP DETACHED FROM THE SALIVA EJECTOR TUBE DURING A DENTAL PROCEDURE. IT WAS REPORTED THAT THE TIP BECAME LODGED IN THE PATIENT'S AIRWAY. THE TIP WAS NOT SWALLOWED AND WAS ABLE TO BE RETRIEVED AND WAS THROWN AWAY.