MAUDE Adverse Event Report: STERIS CORPORATION VAPROX; VAPROX HC STERILANT

Model Number	PB011
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the reported event is in progress; a follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported an employee obtained a burn on their finger while handling a leaking carton of vaprox hc sterilant.No medical treatment was sought or administered and the employee continued working.

• Brand Name: VAPROX
• Common Device Name: VAPROX HC 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: 24830315
• Report Number: 3003950207-2026-00011
• Device Sequence Number: 18431460
• Product Code: MLR
• UDI-Device Identifier: 00724995153090
• UDI-Public: (01)00724995153090(11)250325(17)260625(10)HC0845T4
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K233065
• 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): 04/09/2026

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 Expiration Date: 06/25/2026
• Device Model Number: PB011
• Device Catalogue Number: PB011
• Device Lot Number: (10)HC0845T4
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 04/09/2026
• Date Device Manufactured: 03/25/2025
• 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