MAUDE Adverse Event Report: STERIS CORPORATION - DISTRIBUTION CENTER VAPROX HC STERILANT

Model Number	PB011
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris made multiple attempts to contact the user facility employee to obtain additional information however, no response has been received.The vaprox hc sterilant instructions for use are placed inside each shipping case and 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." a follow- up report will be submitted should additional information become available.No additional issues have been reported.
Event or Problem Description
A user facility employee reported via chemtrec report that while he was "moving a tray of vaprox hc sterilant" some of the product got on his left hand causing a "white burn" on his fingers.It is unknown if medical treatment was sought or administered.

• Brand Name: VAPROX HC STERILANT
• Common Device Name: STERILANT
• Manufacturer (Section D): STERIS CORPORATION - DISTRIBUTION CENTER; 6100 heisley rd; mentor OH 44060
• Manufacturer (Section G): STERIS CORPORATION - DISTRIBUTION CENTER; 6100 heisley rd; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 19231630
• Report Number: 3003950207-2024-00004
• Device Sequence Number: 12265861
• Product Code: MLR
• UDI-Device Identifier: 00724995153090
• UDI-Public: 00724995153090
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/02/2024

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
• Device Model Number: PB011
• Device Catalogue Number: PB011
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 05/02/2024
• 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