MAUDE Adverse Event Report: STERIS CORPORATION VAPROX; VAPROX STERILANT

Model Number	PB011
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Through follow up with user facility personnel it was learned a container of vaprox hc sterilant was damaged and had leaked onto the box.The container was disposed of and not returned for evaluation; the damage is likely attributed to shipping damage.It was additionally learned the employee was not wearing proper ppe, specifically gloves, while handling the box of vaprox 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".A steris account manager counseled the user facility on the importance of wearing proper ppe, specifically gloves, while handling vaprox hc sterilant.The device history record was reviewed and confirmed the devices were manufactured to specification.No additional issues have been reported.
Event or Problem Description
The user facility reported that a bottle of vaprox hc sterilant leaked and contacted an employee's hand.The employee sought medical treatment, however no medical treatment was administered.

• Brand Name: VAPROX
• Common Device Name: VAPROX 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: 24147556
• Report Number: 3003950207-2026-00002
• Device Sequence Number: 8997959
• Product Code: MLR
• UDI-Device Identifier: 00724995153090
• UDI-Public: (01)00724995153090(11)251112(17)270212(10)HC3165T3
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 01/22/2026

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)HC3165T3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown