RAPICIDE HIGH LEVEL DISINFECTANT AND STERILANT

Additional Manufacturer Narrative

A STERIS ACCOUNT MANAGER CONTACTED THE USER FACILITY AND IT WAS REPORTED THAT THE EVENT OCCURRED DURING NORMAL USE. IT IS UNKNOWN WHAT PPE THE EMPLOYEE WAS WEARING AT THE TIME OF THE EVENT. THE RAPICIDE HIGH-LEVEL DISINFECTANT SAFETY DATA SHEET STATES, "AVOID BREATHING DUST/FUME/GAS/MIST/VAPOURS/SPRAY. USE ONLY OUTDOORS OR IN A WELL-VENTILATED AREA. WASH HANDS THOROUGHLY AFTER HANDLING. WEAR PROTECTIVE GLOVES/EYE PROTECTION/FACE PROTECTION. IN CASE OF INADEQUATE VENTILATION WEAR RESPIRATORY PROTECTION. CONTAMINATED WORK CLOTHING MUST NOT BE ALLOWED OUT OF THE WORKPLACE. IF INHALED: REMOVE PERSON TO FRESH AIR AND KEEP COMFORTABLE FOR BREATHING." THE SDS FURTHER STATES, "IN CASE OF INSUFFICIENT VENTILATION, WEAR SUITABLE RESPIRATORY EQUIPMENT. RESPIRATOR SELECTION MUST BE BASED ON KNOWN OR ANTICIPATED EXPOSURE LEVELS, THE HAZARDS OF THE PRODUCT AND THE SAFE WORKING LIMITS OF THE SELECTED RESPIRATOR." THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT WHILE CHANGING OUT THE BOTTLE OF RAPICIDE HIGH-LEVEL DISINFECTANT TO THEIR DSD 201 AUTOMATED ENDOSCOPE REPROCESSOR, AN EMPLOYEE WAS "EXPOSED" TO RAPICIDE HIGH-LEVEL DISINFECTANT AND EXPERIENCED INHALATION/IRRITATION. MEDICAL TREATMENT WAS SOUGHT AND ADMINISTERED.