MAUDE Adverse Event Report: STERIS CORPORATION VAPROX; STERILANT

Model Number	PB011
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Skin Discoloration (2074)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris has made multiple attempts to obtain additional information regarding the reported event however, the user facility has not responded.From the information that was provided by user facility personnel, the reported event may be attributed to shipping/handling damage that the vaprox hc sterilant packing sustained.A follow-up report will be submitted should additional information become available.
Event or Problem Description
The user facility reported that the outside packaging for their vaprox hc sterilant was "damaged" and "wet".An employee proceeded to open the packaging and observed a vaprox hc sterilant cup to be leaking.The employee proceeded to handle the damaged cup and obtained a "burn" to their thumb.It is unknown is medical treatment was sought or administered.

• 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: 20312472
• Report Number: 3003950207-2024-00008
• Device Sequence Number: 7588689
• Product Code: MLR
• UDI-Device Identifier: 00724995153090
• UDI-Public: (01)00724995153090(11)240731(17)251031(10)HC213417
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/26/2024

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: 10/31/2025
• Device Model Number: PB011
• Device Catalogue Number: PB011
• Device Lot Number: (10)HC213417
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2024
• 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