VAPROX HC STERILANT

Description of Event or Problem

THE USER FACILITY REPORTED THAT AN EMPLOYEE HAD OPENED A CASE OF VAPROX STERILANT CARTRIDGES AND UPON REMOVING THE PRODUCT FROM THE CASE THE EMPLOYEE OBTAINED DISCOLORATION TO THEIR HANDS. A SECOND EMPLOYEE ALSO EXPERIENCED DISCOLORATION TO THEIR HANDS. BOTH EMPLOYEES WENT TO THE FACILITY'S EMERGENCY ROOM.

Additional Manufacturer Narrative

THE EMPLOYEES SUBJECT OF THE REPORTED EVENT WERE NOT WEARING GLOVES WHILE HANDLING THE VAPROX STERILANT CARTRIDGES. THERE IS A SHIPPING CASE INSERT THAT STATES TO WEAR CHEMICAL RESISTANT GLOVES. A STERIS ACCOUNT MANAGER DISCUSSED THE REPORTED EVENT WITH USER FACILITY PERSONNEL, AND IT WAS CONFIRMED THAT THE CASE OF VAPROX STERILANT APPEARED TO BE DAMAGED/SMASHED AND STERILANT LEAKING PRIOR TO THE EMPLOYEES REMOVAL OF THE PRODUCT FROM THE CASE. THE STERIS ACCOUNT MANAGER COUNSELED USER FACILITY PERSONNEL ON THE IMPORTANCE OF WEARING CHEMICAL RESISTANT GLOVES. PICTURES WERE TAKEN OF THE DAMAGED CASE OF VAPROX STERILANT WHICH IDENTIFIED THE CARTRIDGE WAS LEAKING THROUGH THE SECONDARY CONTAINMENT (HEAT SEALED PLASTIC BAG) AND DAMAGED THE CARTON. THE CUSTOMER DISPOSED OF THE PRODUCT. A LEAK THROUGH SECONDARY CONTAINMENT OF H2O2 IS MOST LIKELY TO OCCUR WITH EXPOSURE TO FORCES HIGH ENOUGH TO FRACTURE THE CARTRIDGE AND PUNCTURE THE PLASTIC BAG. A PICTURE OF THE ACTUAL CARTRIDGE WAS NOT PROVIDED SO THIS COULD NOT BE CONFIRMED. THE CUSTOMER DISPOSED OF THE PRODUCT FOLLOWING THE EVENT. RETAIN TESTING WAS CONDUCTED ON THE LOT SUBJECT OF THE REPORTED EVENT AND NO ABNORMALITIES WERE NOTED. A COMPLAINT REVIEW WAS CONDUCTED AND CONFIRMED THIS TO BE AN ISOLATED EVENT FOR THE SUBJECT LOT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.