VAPROX
Received Jun 4, 2026 · Event occurred May 5, 2026
Report 3003950207-2026-00015 · MDR key 25394698
Device
Generic name
Sterilant
Manufacturer
Steris CorporationModel number
PB011Catalog number
PB011
Lot number
(10)HC0916W9
Product problems
- Leak/Splash
Patient
NA · Unknown
- Burn(s)
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE NOTICED A BURNING SENSATION ON THEIR THUMB WHILE HANDLING A LEAKING CARTRIDGE OF VAPROX HC STERILANT. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED, AND THE EMPLOYEE CONTINUED WORKING.
Additional Manufacturer Narrative
THROUGH FOLLOW-UP WITH USER FACILITY PERSONNEL, IT WAS LEARNED THAT THE EMPLOYEE OPENED A CASE AND OBSERVED THAT ONE CARTON APPEARED WET. UPON OPENING IT, THE CARTON AND INNER BAG WERE DAMP. THE EMPLOYEE WAS NOT WEARING PROPER PPE WHILE HANDLING THE CASE. THE VAPROX HC STERILANT SAFETY DATA SHEET STATES, "HAND PROTECTION: WEAR PROTECTIVE GLOVES" "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 SHIPPING CASE INSERT ALSO STATES, "WEAR PERSONAL PROTECTIVE EQUIPMENT TO HANDLE CARTRIDGE; CHEMICAL RESISTANT GLOVES". STERIS COUNSELED USER FACILITY PERSONNEL ON THE IMPORTANCE OF WEARING PROPER PPE, SPECIFICALLY GLOVES, WHILE HANDLING VAPROX HC STERILANT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.