BEUDAMED
    FDA Adverse Event Summary report: N

    V-PRO 1 STERILIZER

    MDR report key: 2853361 · Received November 30, 2012

    Report

    Report Number
    3005899764-2012-00088
    Date Received
    November 30, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 30, 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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    STERIS CONDUCTED IN-SERVICE TRAINING ON (B)(4) 2013 ON THE PROPER USE OF PPE.

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE UNIT AND FOUND IT TO BE OPERATING PROPERLY. HE RAN A LEAK TEST AND PROCESSING CYCLE AND CONFIRMED THE UNIT WAS OPERATING PROPERLY. THE EMPLOYEE WAS NOT WEARING PROPER PPE WHEN HANDLING THE INSTRUMENT PACKS AS INSTRUCTED IN THE OPERATOR MANUAL. 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 AN EMPLOYEE REMOVED THE INSTRUMENTS FROM THE STERILIZER AND PLACED THEM IN A BIN FOR RETRIEVAL BY STAFF. A NURSE WENT TO RETRIEVE INSTRUMENTS FOR A PROCEDURE AND WHEN SHE REMOVED THEM FROM THE BIN AND WAS CARRYING THEM TO THE OR SHE BEGAN TO FEEL A TINGLING SENSATION ON THE INSIDE OF HER ELBOW. THE EMPLOYEE RAN HER ARM UNDER COLD WATER AND APPLIED SILVADENE OINTMENT. THE EMPLOYEE THEN WENT TO THE CONCENTRA CLINIC FOR FOLLOW-UP TREATMENT. FURTHER TREATMENT ADMINISTERED AT THE CLINIC WAS NOT PROVIDED BUT THE EMPLOYEE STATED THAT A BLISTER WAS PRESENT. THE EMPLOYEE IS FINE WITH NO SUSTAINING INJURIES. NO PROCEDURAL DELAYS OR CANCELLATIONS WERE REPORTED AND THE INSTRUMENTS PRESENT IN THE CYCLE DURING THE TIME OF THE REPORTED EVENT WERE REPROCESSED BEFORE BEING USED IN PATIENT PROCEDURES

    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