MAUDE Adverse Event Report: STERIS CORPORATION VAPROX HC STERILANT

Model Number	PB012
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported an employee obtained a burn to their arm while removing the vaprox hc sterilant cup from their v-pro sterilizer.Medical treatment was self-administered (ointment), and the employee continued working.
Additional Manufacturer Narrative
The employee subject of the reported event was wearing gloves while handling the sterilant cup.The employee stated that the vaprox cup had a crack at the bottom, which was not visible to the employee as they were unloading the sterilant cup from the sterilizer.The sterilant cup was disposed of and not available for evaluation.The reported event is likely attributed to excessive force placed on the sterilant cup while loading into the sterilizer.The device history record was reviewed for the subject lot and confirmed the lot was manufacturing according to specifications; no abnormalities were noted.A three-year complaint review was performed and confirmed this to be an isolated event.No additional issues have been reported.

• Brand Name: VAPROX HC STERILANT
• Common Device Name: STERILANT
• Manufacturer (Section D): STERIS CORPORATION; 6100 heisley rd; mentor OH 44060
• Manufacturer (Section G): STERIS CORPORATION; 6100 heisley rd; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 21893900
• Report Number: 3003950207-2025-00005
• Device Sequence Number: 12858886
• Product Code: MLR
• UDI-Device Identifier: 00724995153106
• UDI-Public: (01)00724995153106(17)250330(10)HC2744X7
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/23/2025

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: 03/30/2025
• Device Model Number: PB012
• Device Catalogue Number: PB012
• Device Lot Number: (10)HC2744X7
• 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: 03/24/2025
• Initial Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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