BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFY ASSERT STEAM PROCESS CHALLENGE DEVICE

    MDR report key: 7932020 · Received October 3, 2018

    Report

    Report Number
    3004080920-2018-00002
    Event Type
    Malfunction
    Date Received
    October 3, 2018
    Date of Event
    August 31, 2018
    Report Date
    October 3, 2018
    Manufacturer
    STERIS BIOLOGICAL OPERATIONS
    Product Code
    OWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS ACCOUNT MANAGER WENT ONSITE AND SPOKE WITH THE USER FACILITY PERSONNEL REGARDING THE REPORTED EVENT. USER FACILITY PERSONNEL STATED THAT AN EMPLOYEE WENT TO ACTIVATE THE BI AND FOUND THAT THE FOIL SEAL THAT RETAINS THE BI MEDIA WAS DAMAGED AND THAT NO MEDIA REMAINED. DUE TO THE DAMAGE SUSTAINED TO THE FOIL SEAL PRIOR TO USE, THE LIQUID MEDIA INSIDE THE BI WAS REMOVED DURING THE VACUUM PULL PHASE OF THE STERILIZATION CYCLE. THE PROCESS CHALLENGE DEVICE FOR DYNAMIC AIR REMOVAL 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." A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT, INSPECTED THE CENTURY STERILIZER, AND FOUND IT TO BE OPERATING ACCORDING TO SPECIFICATION; NO REPAIRS WERE REQUIRED. RETAIN TESTING WAS PERFORMED ON THE BI LOT NUMBER SUBJECT OF THE REPORTED EVENT; NO ISSUES WERE NOTED. THE DHR WAS REVIEWED AND NO ABNORMALITIES WERE FOUND. WHILE ONSITE, THE STERIS ACCOUNT MANAGER WAS ABLE TO PERFORM IN-SERVICE TRAINING ON PROPER USE OF THE BIOLOGICAL INDICATOR SPECIFICALLY INSPECTING THE FOIL SEAL BEFORE USE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED A DRY BIOLOGICAL INDICATOR (BI) FOLLOWING A PROCESSING CYCLE DURING A PATIENT PROCEDURE. THE INSTRUMENTS WERE REPROCESSED PRIOR TO USE CAUSING A PROCEDURE DELAY. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772257 VERIFY ASSERT STEAM PROCESS CHALLENGE DEVICE VERIFY ASSERT STEAM PROCESS CHALLENGE DEVICE OWP STERIS BIOLOGICAL OPERATIONS 190114

    Patients

    Seq Age Sex Outcome Treatment
    0