BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTROL HEAD /VALVE CLEANING BRUSH

    MDR report key: 8764008 · Received July 5, 2019

    Report

    Report Number
    8764008
    Event Type
    Malfunction
    Date Received
    July 5, 2019
    Date of Event
    June 7, 2019
    Report Date
    June 26, 2019
    Manufacturer
    HEALTHMARK INDUSTRIES CO., INC.
    Product Code
    MNL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 0

    NOTIFICATION RECEIVED FROM INFECTION CONTROL THAT THE STERILE BRUSHES USED TO CULTURE DUODENOSCOPES AFTER PROCESSING TO ENSURE PROPER CLEANING WAS THE SOURCE OF CONTAMINATION FROM THE CULTURE. PER INFECTION CONTROL, EVERY WEEK THE DUODENOSCOPES ARE CULTURED AFTER PROCESSING. THE DEPARTMENT COMPLETES A BRUSH CULTURE AND A FLUSH CULTURE. THE PAST FOUR WEEKS THE BRUSH CULTURE HAS BEEN POSITIVE FOR A BACILLUS SPECIES (<10 CFU) WITH NO GROWTH AFTER 48 HOURS. THE SCOPES WERE TAKEN OUT OF SERVICE AND REPROCESSED. IN ADDITION, AT THE SAME TIME NEW SCOPES WERE ACQUIRED AS A PLANNED REPLACEMENT. ON JUNE 7TH INFECTION CONTROL QUERIED THE MANUFACTURER TO VALIDATE THE BRUSHES WERE STERILE AS IT IS NOT INDICATED ON THE PACKAGING. THE MANUFACTURER INDICATED THAT THE BRUSHES GO THROUGH A ETHYLENE OXIDE STERILIZATION PROCESS. THE COMPANY INDICATES THAT THEY ARE NOT TO BE USED IN STERILE PROCEDURES INVOLVING PATIENT CARE AND THEREFORE THEY DO NOT PLACE THE WORD STERILE ON THE WRAPPER. IN ORDER TO BETTER DETERMINE THE SOURCE, THE BRUSHES WERE CULTURED IMMEDIATELY AFTER REMOVAL FROM THE PACKAGING. THE BRUSH CULTURE WAS POSITIVE FOR PROBABLE BACILLUS SPECIES(<10 CFU). CONSEQUENTLY, THE BRUSHES WERE REMOVED FROM USE AND A REPLACEMENT IS BEING SOUGHT. UPON FURTHER REVIEW, THE HOSPITAL ACKNOWLEDGES THAT THEY PURCHASED THE INCORRECT NON-STERILE BRUSH AND ARE CONCERNED ABOUT THE LABELING OF THE STERILE CLEANING BRUSH PRODUCT VERSES THE NON-STERILE CLEANING BRUSH. THE ONLY DISTINCTION BETWEEN THE STERILE BRUSH AND THE NON-STERILE BRUSH IS THE "S" AT THE END OF THE CATALOG NUMBER FOR BOTH PRODUCTS.

    Description of Event or Problem · 1

    NOTIFICATION RECEIVED FROM INFECTION CONTROL THAT THE STERILE BRUSHES USED TO CULTURE DUODENOSCOPES AFTER PROCESSING TO ENSURE PROPER CLEANING WAS THE SOURCE OF CONTAMINATION FROM THE CULTURE. PER INFECTION CONTROL, EVERY WEEK THE DUODENOSCOPES ARE CULTURED AFTER PROCESSING. THE DEPARTMENT COMPLETES A BRUSH CULTURE AND A FLUSH CULTURE. THE PAST FOUR WEEKS THE BRUSH CULTURE HAS BEEN POSITIVE FOR A BACILLUS SPECIES (<10 CFU) WITH NO GROWTH AFTER 48 HOURS. THE SCOPES WERE TAKEN OUT OF SERVICE AND REPROCESSED. IN ADDITION, AT THE SAME TIME NEW SCOPES WERE ACQUIRED AS A PLANNED REPLACEMENT. ON JUNE 7TH INFECTION CONTROL QUERIED THE MANUFACTURER TO VALIDATE THE BRUSHES WERE STERILE AS IT IS NOT INDICATED ON THE PACKAGING. THE MANUFACTURER INDICATED THAT THE BRUSHES GO THROUGH AN ETHYLENE OXIDE STERILIZATION PROCESS. THE COMPANY INDICATES THAT THEY ARE NOT TO BE USED IN STERILE PROCEDURES INVOLVING PATIENT CARE AND THEREFORE THEY DO NOT PLACE THE WORD STERILE ON THE WRAPPER. IN ORDER TO BETTER DETERMINE THE SOURCE, THE BRUSHES WERE CULTURED IMMEDIATELY AFTER REMOVAL FROM THE PACKAGING. THE BRUSH CULTURE WAS POSITIVE FOR PROBABLE BACILLUS SPECIES(<10 CFU). CONSEQUENTLY, THE BRUSHES WERE REMOVED FROM USE AND A REPLACEMENT IS BEING SOUGHT. UPON FURTHER REVIEW, THE HOSPITAL ACKNOWLEDGES THAT THEY PURCHASED THE INCORRECT NON-STERILE BRUSH AND ARE CONCERNED ABOUT THE LABELING OF THE STERILE CLEANING BRUSH PRODUCT VERSES THE NON-STERILE CLEANING BRUSH. THE ONLY DISTINCTION BETWEEN THE STERILE BRUSH AND THE NON-STERILE BRUSH IS THE "S" AT THE END OF THE CATALOG NUMBER FOR BOTH PRODUCTS.

    Description of Event or Problem · 1

    NOTIFICATION RECEIVED FROM INFECTION CONTROL THAT THE STERILE BRUSHES USED TO CULTURE DUODENOSCOPES AFTER PROCESSING TO ENSURE PROPER CLEANING WAS THE SOURCE OF CONTAMINATION FROM THE CULTURE. PER INFECTION CONTROL, EVERY WEEK THE DUODENOSCOPES ARE CULTURED AFTER PROCESSING. THE DEPARTMENT COMPLETES A BRUSH CULTURE AND A FLUSH CULTURE. THE PAST FOUR WEEKS THE BRUSH CULTURE HAS BEEN POSITIVE FOR A BACILLUS SPECIES (<10 CFU) WITH NO GROWTH AFTER 48 HOURS. THE SCOPES WERE TAKEN OUT OF SERVICE AND REPROCESSED. IN ADDITION, AT THE SAME TIME NEW SCOPES WERE ACQUIRED AS A PLANNED REPLACEMENT. ON JUNE 7TH INFECTION CONTROL QUERIED THE MANUFACTURER TO VALIDATE THE BRUSHES WERE STERILE AS IT IS NOT INDICATED ON THE PACKAGING. THE MANUFACTURER INDICATED THAT THE BRUSHES GO THROUGH A ETHYLENE OXIDE STERILIZATION PROCESS. THE COMPANY INDICATES THAT THEY ARE NOT TO BE USED IN STERILE PROCEDURES INVOLVING PATIENT CARE AND THEREFORE THEY DO NOT PLACE THE WORD STERILE ON THE WRAPPER. IN ORDER TO BETTER DETERMINE THE SOURCE, THE BRUSHES WERE CULTURED IMMEDIATELY AFTER REMOVAL FROM THE PACKAGING. THE BRUSH CULTURE WAS POSITIVE FOR PROBABLE BACILLUS SPECIES(<10 CFU). CONSEQUENTLY, THE BRUSHES WERE REMOVED FROM USE AND A REPLACEMENT IS BEING SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557199 CONTROL HEAD /VALVE CLEANING BRUSH ACCESSORIES, CLEANING BRUSHES, MNL HEALTHMARK INDUSTRIES CO., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1