VAPROX HC STERILANT

Description of Event or Problem

THE USER FACILITY REPORTED AN EMPLOYEE OBTAINED A BURN TO THEIR ARM WHILE REMOVING THE VAPROX HC STERILANT CUP FROM THEIR V-PRO STERILIZER. MEDICAL TREATMENT WAS SELF-ADMINISTERED (OINTMENT), AND THE EMPLOYEE CONTINUED WORKING.

Additional Manufacturer Narrative

THE EMPLOYEE SUBJECT OF THE REPORTED EVENT WAS WEARING GLOVES WHILE HANDLING THE STERILANT CUP. THE EMPLOYEE STATED THAT THE VAPROX CUP HAD A CRACK AT THE BOTTOM, WHICH WAS NOT VISIBLE TO THE EMPLOYEE AS THEY WERE UNLOADING THE STERILANT CUP FROM THE STERILIZER. THE STERILANT CUP WAS DISPOSED OF AND NOT AVAILABLE FOR EVALUATION. THE REPORTED EVENT IS LIKELY ATTRIBUTED TO EXCESSIVE FORCE PLACED ON THE STERILANT CUP WHILE LOADING INTO THE STERILIZER. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE SUBJECT LOT AND CONFIRMED THE LOT WAS MANUFACTURING ACCORDING TO SPECIFICATIONS; NO ABNORMALITIES WERE NOTED. A THREE-YEAR COMPLAINT REVIEW WAS PERFORMED AND CONFIRMED THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.