GLIDERITE SINGLE-USE STYLET - SMALL

Additional Manufacturer Narrative

THE CUSTOMER WAS UNABLE TO RETURN THE GLIDERITE SINGLE-USE STYLET - SMALL TO VERATHON FOR EVALUATION, AS THE DEVICE HAD ALREADY BEEN DISCARDED. BECAUSE THE DEVICE WAS NOT AVAILABLE FOR EVALUATION, THE CAUSE COULD NOT BE DETERMINED; HOWEVER, PREVIOUS INVESTIGATIONS HAVE INDICATED THAT BENDING THE STYLET TO ACCOMMODATE A VERY ANTERIOR AIRWAY POSITION MAY HAVE CAUSED OR CONTRIBUTED TO BREAKAGE. 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.

Description of Event or Problem

A CUSTOMER REPORTED WHILE INTUBATING A PEDIATRIC PATIENT, USING A GLIDERITE SINGLE-USE STYLET - SMALL, THE STYLET BROKE INSIDE A 3.0MM ENDOTRACHEAL TUBE (ET). THE CUSTOMER LUBRICATED THE STYLET AND EMPLOYED THE CORRECT WITHDRAWAL TECHNIQUE. THE CUSTOMER HAD TO EXTUBATE THE PATIENT USING HEMOSTATS TO PREVENT THE BROKEN STYLET FROM FALLING INTO THE TRACHEA. THE CRITICAL CARE TEAM SUBSEQUENTLY TRANSPORTED THE PATIENT TO THE OR, WHERE ANESTHESIA SUCCESSFULLY INTUBATED THE PATIENT USING A HYPERANGLE S2 AND A MALLEABLE STYLET. THE INCIDENT CAUSED AN UNSPECIFIED TIME OF DELAY IN PATIENT CARE; HOWEVER, NO HARM TO THE PATIENT WAS REPORTED.