VAPROX HC STERILANT

Additional Manufacturer Narrative

THE EMPLOYEE SUBJECT OF THE REPORTED EVENT WAS NOT WEARING PROPER PPE, SPECIFICALLY GLOVES, WHILE HANDLING THE VAPROC HC STERILANT. THE VAPROX HC STERILANT SAFETY DATA SHEET STATES (4), "HAND PROTECTION: WEAR PROTECTIVE GLOVES". THE SHIPPING CASE INSERT ALSO STATES, "WEAR PERSONAL PROTECTIVE EQUIPMENT TO HANDLE CARTRIDGE; CHEMICAL RESISTANT GLOVES". THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE SUBJECT LOT AND NO ABNORMALITIES WERE NOTED. A COMPLAINT REVIEW WAS PERFORMED AND CONFIRMED THE EVENT TO BE ISOLATED FOR THE SUBJECT LOT. USER FACILITY PERSONNEL WERE COUNSELED ON THE PROPER USE AND HANDLING FOR VAPROX HC STERILANT AND THE IMPORTANCE OF WEARING GLOVES. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED AN EMPLOYEE OBTAINED A BURN TO THEIR HAND WHILE OPENING A BOTTLE OF THEIR VAPROX HC STERILANT. MEDICAL TREATMENT WAS SOUGHT AND ADMINISTERED (OINTMENT); THE EMPLOYEE RETURNED TO WORK.