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

Model Number	PB011
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported to anvisa that their vpro max 2 sterilizer did not recognize a vaprox hc sterilant cup upon insertion.The user facility then inserted a different vaprox hc sterilant cup from the same lot and no issues were noted.No report of injury.
Additional Manufacturer Narrative
Following notification of the reported event, steris quality requested that the cup subject of the event be returned for evaluation.The investigation of the subject event is in process.A follow-up mdr will be submitted when additional information becomes available.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the vpro max 2 sterilizer and found the unit to be operating properly.No repairs were required, and the unit was returned to service.The cup subject of the event was not returned for evaluation.Without a returned cup, the root cause cannot be determined.The device history records 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.No additional issues have been reported.

• Brand Name: VAPROX 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: 14578391
• Report Number: 3003950207-2022-00001
• Device Sequence Number: 5077573
• Product Code: MLR
• UDI-Device Identifier: 00724995153090
• UDI-Public: 00724995153090
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2022

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: HC2101P7
• 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: 05/09/2022
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2021
• 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