MAUDE Adverse Event Report: STERIS CORPORATION VAPROX; STERILANT

Model Number	PB011
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
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 shipping personnel reported via chemtrec report that a fire was observed on their shipping truck while storing vaprox hc sterilant in the truck's cab.The fire department was dispatched.No report of injury.
Additional Manufacturer Narrative
The single case of vaprox hc sterilant was destroyed in the fire and therefore was not available for evaluation.The transportation company where the event occurred reported that the case of sterilant had been dropped by shipping personnel prior to being placed into the truck's cab.Evidence indicates that the reported impact of the case being dropped was significant enough to damage at least one cup of vaprox inside the case, causing it to leak and combust with the cardboard box, resulting in the reported event.A copy of the vaprox hc sterilant safety data sheet has been re-provided to the transportation company.The vaprox hc sterilant safety data sheet states, "precautionary statements - keep away from heat, hot surfaces, sparks, open flames and other ignition sources.Combustible materials exposed to hydrogen peroxide should be immediately submerged in or rinsed with large amounts of water to ensure that all hydrogen peroxide is removed.Residual hydrogen peroxide that is allowed to dry (upon evaporation hydrogen peroxide can concentrate) on organic materials such as paper, fabrics, cotton, leather, wood or other combustibles can cause the material to ignite and result in fire.Storage conditions - store in a cool, well ventilated place." no additional issues have been reported.

• Brand Name: VAPROX
• 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: 22153398
• Report Number: 3003950207-2025-00006
• Device Sequence Number: 9254980
• Product Code: MLR
• UDI-Device Identifier: 00724995153090
• UDI-Public: (01)00724995153090(11)250325(17)260624(10)HC0835T3
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2025

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: 06/24/2026
• Device Model Number: PB011
• Device Catalogue Number: PB011
• Device Lot Number: (10)HC0835T3
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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