MAUDE Adverse Event Report: STERIS CORPORATION VAPROX; STERILANT

Model Number	PB011
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• Brand Name: VAPROX
• Common Device Name: STERILANT
• Manufacturer (Section D): STERIS CORPORATION; 6100 heisley road; mentor OH 44060
• Manufacturer (Section G): STERIS CORPORATION; 6100 heisley road; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 25394698
• Report Number: 3003950207-2026-00015
• Device Sequence Number: 5191769
• Product Code: MLR
• UDI-Device Identifier: 00724995153090
• UDI-Public: (01)00724995153090(11)260401(17)270701(10)HC0916W9
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PB011
• Device Catalogue Number: PB011
• Device Lot Number: (10)HC0916W9
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown