BEUDAMED
    FDA Adverse Event Summary report: N

    V-PRO 1 STERILIZER

    MDR report key: 2840717 · Received November 20, 2012

    Report

    Report Number
    3005899764-2012-00084
    Date Received
    November 20, 2012
    Date of Event
    October 24, 2012
    Report Date
    November 20, 2012
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    MLR
    PMA / PMN Number
    K083097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE STERIS ACCOUNT MANAGER PROVIDED THE USER FACILITY WITH AN IN-SERVICE ON PROPER PPE AND HANDLING INSTRUCTIONS FOR VAPROX.

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE UNIT AND WAS UNABLE TO DUPLICATE THE REPORTED EVENT. THE SERVICE TECHNICIAN INSPECTED THE CYCLE TAPES; THE CYCLES PASSED, AS DID THE INDICATORS. THE UNIT WAS FOUND TO BE OPERATING PROPERLY. THE EMPLOYEES WERE NOT WEARING GLOVES WHILE UNLOADING THE ITEMS FROM THE UNIT. THE OPERATOR MANUAL STATES (PG. 1-2),"ANY VISIBLE LIQUIDS IN THE CHAMBER MUST BE TREATED AS CONCENTRATED HYDROGEN PEROXIDE. OBSERVE ALL HYDROGEN PEROXIDE HANDLING PRECAUTIONS. REFER TO THE VAPROX HC STERILANT MATERIAL SAFETY DATA SHEET. WHEN HANDLING HYDROGEN PEROXIDE, WEAR APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT." THE OPERATOR MANUAL STATES (2-1), "PPE - PERSONAL PROTECTIVE EQUIPMENT INCLUDING GOGGLES OR FACE SHIELD AND CHEMICAL-RESISTANT GLOVES. PPE REQUIRED PER TASK WILL VARY DEPENDING UPON HAZARDS OF THE TASK." STERIS WILL OFFER AN IN-SERVICE TO THE CUSTOMER ON PROPER USE OF PPE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AFTER A COMPLETED CYCLE, RESIDUE WAS OBSERVED ON THE INSTRUMENT WRAPS. THE USER FACILITY REPORTED THAT TWO EMPLOYEES EXPERIENCED THEIR HANDS "TURNING WHITE" AFTER COMING INTO CONTACT WITH THE RESIDUE. ONE EMPLOYEE RINSED THE AFFECTED FINGERTIPS AND REPORTED NO PAIN. THE EMPLOYEE DID NOT SEEK FURTHER TREATMENT. ONE EMPLOYEE REPORTED A BURNING SENSATION ON THE AFFECTED HAND. THE EMPLOYEE SOUGHT MEDICAL TREATMENT IN THE ER. SILVADENE CREAM WAS APPLIED TO THE HAND. NO PROCEDURAL DELAYS OR CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-PRO 1 STERILIZER STERILIZER MLR STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other