MAUDE Adverse Event Report: STERIS CORPORATION VAPROX; STERILANT

Model Number	PB011
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee experienced pain to their hands after changing a cup of vaprox hc sterilant.The employee washed their hands with water and continued working.No medical treatment was sought or administered.
Additional Manufacturer Narrative
Through follow-up with user facility personnel, it was stated that the employee was not wearing gloves while handling the vaprox hc sterilant cup.The vaprox hc sterilant instructions for use states: "wear personal protective equipment to handle cartridge; chemical resistant gloves." "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." every assembled vaprox hc sterilant cup is placed into plastic bag and sealed.The bag states: "warning - wear chemical resistant gloves prior to opening sealed bag." user facility personnel further provided a picture of the vaprox hc sterilant cup subject of the reported event and observed that a small crack was present near the seal of the sterilant cup.Due to the small crack in the seal, hydrogen peroxide solution may have leaked out causing the employee to experience discomfort while handing the sterilant cup.User facility personnel were counseled on the proper use and handling of vaprox hc sterilant and specifically the importance of wearing proper ppe (gloves).The device history record (dhr) was reviewed and confirmed the lot was manufactured to specifications; no abnormalities were noted.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: 20359925
• Report Number: 3003950207-2024-00009
• Device Sequence Number: 20635262
• Product Code: MLR
• UDI-Device Identifier: 00724995153090
• UDI-Public: (01)00724995153090(11)240123(17)250422(10)HC0224W8
• 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): 10/03/2024

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: 04/22/2025
• Device Model Number: PB011
• Device Catalogue Number: PB011
• Device Lot Number: (10)HC0224W8
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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