BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPROX HC STERILANT

    MDR report key: 22196821 · Received June 12, 2025

    Report

    Report Number
    3003950207-2025-00007
    Event Type
    Malfunction
    Date Received
    June 12, 2025
    Date of Event
    May 14, 2025
    Report Date
    June 12, 2025
    Manufacturer
    STERIS CORPORATION
    Product Code
    MLR
    UDI-DI
    00724995225551
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTRARY TO THE FOLLOW-UP REPORT (3003950207-2025-00007-01), THE DEVICE HISTORY RECORD AND RETAIN SAMPLES WERE REVIEWED AND CONFIRMED THE LOT WAS MANUFACTURED TO SPECIFICATIONS; NO ABNORMALITIES WERE NOTED. WITHOUT THE RETURNED DEVICE, THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE DEVICE SUBJECT OF THE REPORTED EVENT WAS RETURNED TO STERIS FOR EVALUATION. THE CAUSE OF THE REPORTED "LEAKING" CARTRIDGES COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE FOR THE VAPROX HC STERILANT STATES, "WARNING - DO NOT USE IF STERILANT PACKAGING IS DAMAGED." "PRECAUTIONARY STATEMENTS IF ON SKIN (OR HAIR): TAKE OFF IMMEDIATELY ALL CONTAMINATED CLOTHING. RINSE SKIN WITH WATER / SHOWER." THE USER FACILITY EMPLOYEE WAS COUNSELED ON THE PROPER USE AND HANDLING FOR VAPROX HC STERILANT. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SUBJECT OF THE REPORTED EVENT WAS REVIEWED AND CONFIRMED THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS; NO ABNORMALITIES WERE NOTED. A COMPLAINT REVIEW WAS PERFORMED AND CONFIRMED THE EVENT TO BE ISOLATED FOR THE SUBJECT LOT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Additional Manufacturer Narrative · 0

    OUR INVESTIGATION INTO THE REPORTED EVENT IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. IT SHOULD BE NOTED THAT THIS SPECIFIC MODEL IS NOT SOLD IN THE UNITED STATES, SO IT IS NOT IN GUDID.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED AN EMPLOYEE WAS SPLASHED IN THE FACE WHILE HANDLING A BOX OF THEIR VAPROX HC STERILANT CARTRIDGES. IT IS UNKNOWN IF THE EMPLOYEE SOUGHT OR RECEIVED MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2152035 VAPROX HC STERILANT VAPROX HC STERILANT MLR STERIS CORPORATION PB007 (10)HC2144P1 00724995225551

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown