KENDALL

Additional Manufacturer Narrative

THE CONTACT OFFICE - MANUFACTURING SITE ADDRESS WAS UPDATED IN SECTION G.

Additional Manufacturer Narrative

A DEVICE HISTORY RECORD REVIEW FOR THE REPORTED LOT NUMBER WAS CONDUCTED. ALL IN-PROCESS AND FINAL ACCEPTANCE INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH ESTABLISHED PROCEDURES. INSPECTION RESULTS WERE WITHIN ACCEPTABLE LIMITS, AND NO MANUFACTURING OR INSPECTION ANOMALIES RELATED TO THE REPORTED ISSUE WERE IDENTIFIED. NO SAMPLES OR PHOTOS WERE PROVIDED FOR REVIEW, SO THIS COMPLAINT COULD NOT BE CONFIRMED NOR A ROOT CAUSE DETERMINED. NO NEW ACTIONS WILL BE TAKEN. IF ADDITIONAL INFORMATION IS RECEIVED, THIS COMPLAINT WILL BE REOPENED. THIS COMPLAINT WILL BE TRACKED AND TRENDED TO DETERMINE IF THERE IS A NEED FOR FURTHER ACTIONS.

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

Description of Event or Problem

THE CUSTOMER REPORTED A PATIENT INJURY OCCURRED AROUND 10:02AM ON (B)(6) 2026 WHEN USING CARDINAL HEALTH MATERIAL # 33134. IT WAS STATED THAT THE LEAD WIRE CAUGHT FIRE, AND DAMAGE HAPPENED TO PATIENT AND EQUIPMENT. THEY BELIEVE THE LOT NUMBER WAS K251013B BASED ON SUPPLY IN THE CLEAN UTILITY ROOM.