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

Model Number LCB033

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 299069701
• Report Number: 3004080920-2022-00005
• Device Sequence Number: 1
• Product Code: OWP
• UDI-Device Identifier: 10724995153035
• UDI-Public: 10724995153035
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 08/04/2022
• Initial Date FDA Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1