BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFY ASSERT STEAM PROCESS CHALLENGE DEVICE

    MDR report key: 8134626 · Received December 5, 2018

    Report

    Report Number
    3004080920-2018-00003
    Event Type
    Malfunction
    Date Received
    December 5, 2018
    Date of Event
    November 5, 2018
    Report Date
    December 5, 2018
    Manufacturer
    STERIS BIOLOGICAL OPERATIONS
    Product Code
    OWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. 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 IN THE STERRAD UNIT. 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." RETAIN TESTING WAS PERFORMED ON THE LOT NUMBER SUBJECT OF THE REPORTED EVENT; NO ISSUES WERE NOTED, THE FOIL SEAL WAS FOUND TO BE INTACT. 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. THE INSTRUMENTS HAD TO BE REPROCESSED PRIOR TO USE CAUSING A PROCEDURE DELAY. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972667 VERIFY ASSERT STEAM PROCESS CHALLENGE DEVICE VERIFY ASSERT STEAM PROCESS CHALLENGE DEVICE OWP STERIS BIOLOGICAL OPERATIONS 20190501F

    Patients

    Seq Age Sex Outcome Treatment
    1