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

Model Number	PB011
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility stated that the case of vaprox hc sterilant was delivered with concealed damage.The employee subject of the reported event was not wearing gloves at the time of the reported event.The employee was counseled on the importance of wearing chemical resistant gloves while handling vaprox hc sterilant.The shipping case insert and cartridge bag states to wear chemical resistant gloves.Pictures of the vaprox hc sterilant case were taken by user facility personnel and reviewed by steris manufacturing.Review of the pictures found deterioration of the shipping case and top of a carton.The source of deterioration may be attributed to a leak.The leak may be due to impact damage to the shipping case and transit or storing the shipping case in a non-upright position.The device history record was reviewed and confirmed that the lot was manufactured to specification; no abnormalities were found.There have been no other complaints associated with this lot.
Event or Problem Description
The user facility reported that upon opening a case of vaprox hc sterilant an employee stated she felt a burning feeling on her finger.The employee washed her finger with water.No 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: 16158623
• Report Number: 3003950207-2023-00001
• Device Sequence Number: 7507961
• Product Code: MLR
• UDI-Device Identifier: 00724995153090
• UDI-Public: 00724995153090
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 01/13/2023

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
• Device Lot Number: HC2992R7
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 01/13/2023
• Date Device Manufactured: 10/26/2022
• 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