VAPROX HC STERILANT

Additional Manufacturer Narrative

CONTRARY TO THE FOLLOW-UP REPORT (3003950207-2025-00007-01), THE DEVICE HISTORY RECORD AND RETAIN SAMPLES WERE REVIEWED AND CONFIRMED THE LOT WAS MANUFACTURED TO SPECIFICATIONS; NO ABNORMALITIES WERE NOTED. WITHOUT THE RETURNED DEVICE, THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED.

Additional Manufacturer Narrative

OUR INVESTIGATION INTO THE REPORTED EVENT IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. IT SHOULD BE NOTED THAT THIS SPECIFIC MODEL IS NOT SOLD IN THE UNITED STATES, SO IT IS NOT IN GUDID.

Description of Event or Problem

THE USER FACILITY REPORTED AN EMPLOYEE WAS SPLASHED IN THE FACE WHILE HANDLING A BOX OF THEIR VAPROX HC STERILANT CARTRIDGES. IT IS UNKNOWN IF THE EMPLOYEE SOUGHT OR RECEIVED MEDICAL TREATMENT.

Additional Manufacturer Narrative

THE DEVICE SUBJECT OF THE REPORTED EVENT WAS RETURNED TO STERIS FOR EVALUATION. THE CAUSE OF THE REPORTED "LEAKING" CARTRIDGES COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE FOR THE VAPROX HC STERILANT STATES, "WARNING - DO NOT USE IF STERILANT PACKAGING IS DAMAGED." "PRECAUTIONARY STATEMENTS IF ON SKIN (OR HAIR): TAKE OFF IMMEDIATELY ALL CONTAMINATED CLOTHING. RINSE SKIN WITH WATER / SHOWER." THE USER FACILITY EMPLOYEE WAS COUNSELED ON THE PROPER USE AND HANDLING FOR VAPROX HC STERILANT. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SUBJECT OF THE REPORTED EVENT WAS REVIEWED AND CONFIRMED THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS; NO ABNORMALITIES WERE NOTED. A COMPLAINT REVIEW WAS PERFORMED AND CONFIRMED THE EVENT TO BE ISOLATED FOR THE SUBJECT LOT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.