GLIDERITE RIGID STYLET

Description of Event or Problem

A CUSTOMER REPORTED DURING A DIFFICULT INTUBATION, USING A GLIDERITE RIGID STYLET, THE LOWER PART OF THE HANDLE BROKE OFF WHEN WITHDRAWING THE STYLET FROM THE ENDOTRACHEAL (ET) TUBE. IT WAS REPORTED THAT THE BROKEN PIECE COMPLETELY BLOCKED THE ET TUBE LUMEN, REQUIRING RE-INTUBATION OF THE PATIENT. NO PIECE OF THE STYLET HANDLE WAS REPORTED TO HAVE FALLEN INTO THE PATIENT. NO HARM TO THE PATIENT WAS REPORTED. THE DATE OF INCIDENT WAS NOT REPORTED.

Additional Manufacturer Narrative

THE REPORTED GLIDERITE RIGID STYLET WAS NOT RETURNED TO VERATHON FOR EVALUATION, THEREFORE THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE DETERMINED. REVIEW OF PHOTO EVIDENCE PROVIDED SHOWS A PORTION OF THE SEPARATED STYLET HANDLE INSIDE THE LUMEN OF A RUSCH 7.5 ID ORAL-NASAL ET TUBE. NO IDENTIFYING INFORMATION IS VISIBLE FROM THE PHOTO OF THE STYLET TO CONFIRM ITS LOT NUMBER OR DATE OF MANUFACTURE. IT IS UNKNOWN HOW MANY REPROCESSING CYCLES THE STYLET UNDERWENT OR IF THE HANDLE WAS ALREADY DAMAGED PRIOR TO THE REPORTED INCIDENT. TRENDING ANALYSIS FOR GLIDERITE RIGID STYLETS DOES NOT IDENTIFY ANY TRENDS EXCEEDING ACCEPTABLE LIMITS. VERATHON CONFIRMED THAT THE RISK ASSOCIATED WITH THE HAZARDOUS SCENARIO HAS BEEN ADEQUATELY CAPTURED AND CHARACTERIZED PER THE SYSTEM RISK ASSESSMENT. CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME. VERATHON WILL CONTINUE TO MONITOR FOR TRENDS.