GLIDERITE SINGLE-USE STYLET - SMALL

Description of Event or Problem

A CUSTOMER REPORTED WHILE TRYING TO INTUBATE DURING A PEDIATRIC CODE, THE GLIDERITE SINGLE-USE STYLET - SMALL SNAPPED. IT WAS FURTHER REPORTED THAT DURING THE INTUBATION ATTEMPT, THEY NEEDED TO MODIFY THE ANGLE OF APPROACH OF THE ENDOTRACHIAL TUBE TO AND THROUGH THE VISIBLE CORDS; BUT WHEN THAT WAS ATTEMPTED, THE STYLET BROKE. ANOTHER ENDOTRACHEAL TUBE WAS OBTAINED AND USED IN PLACE OF THE INITIAL ONE. IT WAS REPORTED THAT THE EMERGENT INTUBATION WAS DELAYED BUT ALL ENDED WELL FOR THE PATIENT. NO FOREIGN BODY WAS IDENTIFIED IN THE TRACHEA AND NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

THE CUSTOMER WAS UNABLE TO RETURN THE GLIDERITE SINGLE-USE STYLET - SMALL TO VERATHON FOR EVALUATION, AS THE DEVICE WAS NO LONGER AVAILABLE. BECAUSE THE DEVICE WAS NOT AVAILABLE FOR EVALUATION, THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED; HOWEVER, PREVIOUS INVESTIGATIONS HAVE INDICATED THAT BENDING OR RESHAPING THE STYLET MAY CAUSE OR CONTRIBUTE TO STYLET BREAKAGE. IN COMMUNICATION WITH A VERATHON REPRESENTATIVE FOLLOWING THE INCIDENT, THE CUSTOMER REQUESTED A MALLEABLE BLUNT STYLET APPROPRIATE FOR PEDIATRICS, STATING THAT THE CURRENT STYLETS ARE NON-MALLEABLE - A FACT DISCOVERED DURING THE PEDIATRIC CODE WHEN MODIFICATION OF THE ANGLE OF APPROACH OF THE ENDOTRACHEAL TUBE WAS ATTEMPTED AND THE STYLET BROKE. THIS BEHAVIOR IS CONSISTENT WITH BENDING OR RESHAPING THE STYLET. THE PRODUCT INSTRUCTIONS FOR USE CONTAINS A WARNING WHICH STATES: "DO NOT ATTEMPT TO BEND OR RESHAPE THE STYLET." REVIEW OF COMPLAINT HISTORY FOR THE REPORTED LOT NUMBER DID NOT IDENTIFY ANY PREVIOUS COMPLAINTS REPORTED TO VERATHON. TRENDING ANALYSIS FOR THE GLIDERITE SINGLE-USE STYLETS DOES NOT IDENTIFY ANY TRENDS EXCEEDING ACCEPTABLE LIMITS. VERATHON HAS CONFIRMED THAT THE RISK ASSOCIATED WITH THIS HAZARDOUS SCENARIO IS ADEQUATELY CAPTURED AND CHARACTERIZED IN THE SYSTEM RISK ASSESSMENT. CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME. VERATHON WILL CONTINUE TO MONITOR FOR ANY ONGOING TRENDS.