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	11/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee experienced a burn after a cup of vaprox hc sterilant leaked onto their hand.The employee sought medical treatment; however, it is unknown what type of medical treatment was administered.
Additional Manufacturer Narrative
The employee subject of the reported event was not wearing proper ppe, specifically gloves at the time of the reported event.The ifu for the vaprox hc sterilant states, "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 employee was counseled on the importance of wearing chemical resistant gloves while handling vaprox hc sterilant.The device history record for the lot number subject of the reported event was reviewed and no abnormalities were noted.There have been no other complaints associated with this lot.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: 20757575
• Report Number: 3003950207-2024-00010
• Device Sequence Number: 18283127
• Product Code: MLR
• UDI-Device Identifier: 00724995153090
• UDI-Public: (01)00724995153090(11)231212(17)250312(10)HC3463T1
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 11/21/2024

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: 03/12/2025
• Device Model Number: PB011
• Device Catalogue Number: PB011
• Device Lot Number: (10)HC3463T1
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2023
• 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