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

Model Number	PB011
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	Skin Discoloration (2074)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee had opened a case of vaprox sterilant cartridges and upon removing the product from the case the employee obtained discoloration to their hands.A second employee also experienced discoloration to their hands.Both employees went to the facility's emergency room.
Additional Manufacturer Narrative
The employees subject of the reported event were not wearing gloves while handling the vaprox sterilant cartridges.There is a shipping case insert that states to wear chemical resistant gloves.A steris account manager discussed the reported event with user facility personnel, and it was confirmed that the case of vaprox sterilant appeared to be damaged/smashed and sterilant leaking prior to the employees removal of the product from the case.The steris account manager counseled user facility personnel on the importance of wearing chemical resistant gloves.Pictures were taken of the damaged case of vaprox sterilant which identified the cartridge was leaking through the secondary containment (heat sealed plastic bag) and damaged the carton.The customer disposed of the product.A leak through secondary containment of h2o2 is most likely to occur with exposure to forces high enough to fracture the cartridge and puncture the plastic bag.A picture of the actual cartridge was not provided so this could not be confirmed.The customer disposed of the product following the event.Retain testing was conducted on the lot subject of the reported event and no abnormalities were noted.A complaint review was conducted and confirmed this to be an isolated event for the subject lot.No additional issues have been reported.

• 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: 18857343
• Report Number: 3003950207-2024-00002
• Device Sequence Number: 3314469
• Product Code: MLR
• UDI-Device Identifier: 00724995153090
• UDI-Public: 00724995153090
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PB011
• Device Catalogue Number: PB011
• Device Lot Number: HC0024T8
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2024
• 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