BEUDAMED
    FDA Adverse Event Summary report: N

    S40 CONCENTRATE

    MDR report key: 3942027 · Received July 17, 2014

    Report

    Report Number
    3000251274-2014-00062
    Date Received
    July 17, 2014
    Date of Event
    June 23, 2014
    Report Date
    July 17, 2014
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN CONTACTED THE FACILITY TO ARRANGE AN INSPECTION OF THE SYSTEM 1E PROCESSOR FOLLOWING THE REPORTED EVENT. THE TECHNICIAN WAS INFORMED THAT THE SYSTEM 1E UNIT WAS NOT ONSITE AS IT WAS BEING EVALUATED BY A THIRD PARTY SERVICE PROVIDER EMPLOYED BY THE FACILITY. THE FACILITY STATED THEY ARE COMPETING AN INDEPENDENT INVESTIGATION INTO THE INCIDENT AND DID NOT WISH TO HAVE STERIS INSPECT THE SYSTEM 1E. THE EMPLOYEE WAS NOT WEARING GLOVES AT THE TIME THE S40 CONTACTED HER WRIST. THE SYSTEM 1E OPERATOR MANUAL (1-3) STATES, "CAUTION: APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE) IS REQUIRED WHEN HANDLING CONTAINERS OF S40 STERILANT CONCENTRATE. MINIMALLY, PPE SHOULD CONSIST OF CHEMICAL-RESISTANT GLOVES, APRON, GOGGLES, OR FACE SHIELD, AND ANY OTHER PROTECTION REQUIRED BY FACILITY PROCEDURES." THE USER FACILITY'S ACCOUNT MANAGER OFFERED IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE SYSTEM 1E INCLUDING THE REQUIRED PPE, HOWEVER, THE USER FACILITY DECLINED. THE SYSTEM 1E WAS INSTALLED IN (B)(6) OF 2012 AND IS NOT UNDER STERIS SERVICE CONTRACT. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED S40 STERILANT CONCENTRATE CONTACTED AN EMPLOYEE'S WRIST WHEN REMOVING A CUP FROM THE SYSTEM 1E PROCESSOR. THE EMPLOYEE WAS NOT WEARING GLOVES AT THE TIME OF THE EVENT. THE EMPLOYEE FLUSHED HER WRIST WITH WATER AND WAS SENT TO ON-SITE OCCUPATIONAL HEALTH FOR EVALUATION. THE FACILITY DID NOT PROVIDE ADDITIONAL INFORMATION REGARDING ANY ADVERSE SIDE EFFECTS REPORTED BY THE EMPLOYEE OR WHETHER MEDICAL TREATMENT WAS ADMINISTERED. NO PROCEDURAL DELAYS/CANCELLATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418683 S40 CONCENTRATE STERILANT MED STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other