VAPROX

Description of Event or Problem

THE USER FACILITY REPORTED AN EMPLOYEE OBTAINED A BURN ON THEIR HANDS WHILE HANDLING A LEAKING CARTON OF VAPROX HC STERILANT. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED AND THE EMPLOYEE CONTINUED WORKING.

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 CAUSE OF THE REPORT LEAK COULD NOT BE DETERMINED; HOWEVER, IT IS LIKELY THAT THE PACKAGE WAS DAMAGED DURING SHIPPING AND TRANSPORTATION. 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.

Additional Manufacturer Narrative

INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE 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 OBTAINED A BURN ON THEIR HANDS WHILE HANDLING A LEAKING PACKAGE OF VAPROX HC STERILANT. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.