inforMED
MalfunctionMLR

VAPROX

Received Jun 4, 2026 · Event occurred May 5, 2026

Report 3003950207-2026-00015 · MDR key 25394698

Device

Generic name

Sterilant

Manufacturer

Steris Corporation

Model number

PB011

Catalog 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.