MAUDE Adverse Event Report: STERIS CORPORATION VERIFY ASSERT STEAM STERIS; BIOLOGICAL STERILIZATION PROCESS INDICATOR WITH RECOMBINANT-DNA PLASMID

Model Number LCB033

Device Problem Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 07/19/2022

Event Type  malfunction  

Event Description

Biological tests run for autoclaves received from manufacturer defective.Unable to determine defect as we have received dried up control containers and biological tests have been found dry after running through loads, and prior to being run as well.These are affecting our daily process of sterilizing our instruments important for infection control.Fda safety report id # (b)(4).

• Brand Name: VERIFY ASSERT STEAM STERIS
• Type of Device: BIOLOGICAL STERILIZATION PROCESS INDICATOR WITH RECOMBINANT-DNA PLASMID
• Manufacturer (Section D): STERIS CORPORATION
• MDR Report Key: 15094901
• MDR Text Key: 296602687
• Report Number: MW5111090
• Device Sequence Number: 1
• Product Code: OWP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/21/2022

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 Expiration Date: 08/23/2023
• 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: Not provided
• Initial Date FDA Received: 07/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR