MAUDE Adverse Event Report: STERIS CORPORATION VERIFY ASSERT STEAM PROCESS CHALLENGE DEVICE

Model Number	LCB033
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No procedure delays have been reported.Retain testing was performed on the lot number subject of the reported event; no issues were noted.The dhr for the subject lot was reviewed and no abnormalities were found.The process challenge device instructions for use (pg.1) states, "instructions for use: before use, examine the pcd to ensure that the foil and seal are intact.Examine the integrator through the plastic, to ensure the pcd has not been used previously." no additional issues have been reported.
Event or Problem Description
The user facility reported via medwatch (mw5111090) that they received "dried up" control containers and that their biological tests have been found dry prior to and after processing.No report of injury.

• Brand Name: VERIFY ASSERT STEAM PROCESS CHALLENGE DEVICE
• Common Device Name: VERIFY ASSERT STEAM PROCESS CHALLENGE DEVICE
• Manufacturer (Section D): STERIS CORPORATION; 9325 pinecone dr; mentor OH 44060
• Manufacturer (Section G): STERIS CORPORATION; 9325 pinecone dr.; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 15335443
• Report Number: 3004080920-2022-00005
• Device Sequence Number: 17763881
• Product Code: OWP
• UDI-Device Identifier: 10724995153035
• UDI-Public: 10724995153035
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/01/2022

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
• Operator of Device: Health Professional
• Device Model Number: LCB033
• Device Catalogue Number: LCB033
• Device Lot Number: 20230823
• 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: 08/04/2022
• Initial Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2022
• 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