BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ HEKTOEN ENTERIC AGAR

    MDR report key: 15531491 · Received October 3, 2022

    Report

    Report Number
    1119779-2022-01262
    Event Type
    Malfunction
    Date Received
    October 3, 2022
    Date of Event
    September 12, 2022
    Report Date
    April 8, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSI
    UDI-DI
    10382902213663
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE#: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: DURING MANUFACTURING OF MATERIAL 221366 MEDIA IS FORMULATED AND SENT THROUGH A HIGH TEMPERATURE SHORT TIME STERILIZER TO REMOVE BIOBURDEN. THE PETRI DISHES ARE SUBJECTED TO UV RADIATION TO DECREASE BIOBURDEN. THE PETRI DISHES ARE FILLED IN A POSITIVE PRESSURE HEPA FILTERED ENVIRONMENT. THE FILLED PLATES ARE COOLED AND IMMEDIATELY WRAPPED INTO SLEEVES TO DECREASE THE INTRODUCTION OF MICROBES. SLEEVES ARE THEN PACKAGED INTO CARTONS AND THEN TRANSFERRED TO A REFRIGERATED TRUCK (2 TO 8 DEGREES C) FOR SHIPMENT TO THE DISTRIBUTOR. BD DISTRIBUTORS ARE PROVIDED WITH THE STORAGE GUIDELINES FOR THE SHIPPING AND HANDLING OF BD MEDIA OF 2 TO 8 DEGREES C IN A DARK PLACE. THE BATCH HISTORY RECORD FOR BATCH 2221363 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE BIOBURDEN TESTING. A SAMPLE OF PLATES ARE INCUBATED AT 25 DEGREES C AND AT 35 DEGREES C FOR APPROXIMATELY 72 HOURS. ALL BIOBURDEN TESTING PERFORMED ON THIS BATCH WAS SATISFACTORY PER BD INTERNAL PROCEDURES. AFFECTED PRODUCT DOES NOT HAVE ANY STERILITY CLAIMS; THE PRODUCT IS TESTED FOR BIOBURDEN PRIOR TO RELEASE TO ENSURE THAT IT CONFORMS TO PRODUCT SPECIFICATIONS. HOWEVER, THIS DOES NOT ENSURE THAT THE END-USER WILL NOT RECEIVE A CONTAMINATED PLATE. THE COMPLAINT HISTORY WAS REVIEWED AND ONE OTHER COMPLAINT HAS BEEN TAKEN ON BATCH 2221363 FOR CONTAMINATION. RETENTION SAMPLES FROM BATCH 2221363 WERE NOT AVAILABLE FOR INSPECTION. A TOTAL OF 194 PLATES FROM BATCH 2221363 WERE RETURNED AS LOOSE PLATES IN 100PACK CARTONS SHIPPED IN A BOX BIOHAZARD BAG PADDING (TIME STAMPS 0748, 0749, 0743, 0744, 0749). PLATES WERE INSPECTED, AND 15/194 PLATES HAD SURFACE MICROBIAL GROWTH. ONE AFFECTED PLATE WAS SUBMITTED TO THE ID LAB AND PSEUDOMONAS FLUORESCENS WAS IDENTIFIED. SIX PHOTOS ALSO WERE RECEIVED FOR INVESTIGATION. THREE PHOTOS EACH SHOW THE AGAR SURFACE OF AN OPENED PLATE FROM BATCH 2221363 (TIME STAMP 0748) WITH SURFACE MICROBIAL GROWTH AMONG SOME DRIED SURFACE MOISTURE (WHICH IS NOT A DEFECT). ONE PHOTO FEATURES A CARTON LABEL FROM BATCH 2221363 (CARTON NUMBER 0040) FOR BATCH VERIFICATION. THE LAST TWO PHOTOS EACH SHOW THE AGAR SURFACE OF AN OPENED PLATE WITH BACTERIAL COLONIES. THIS COMPLAINT HAS BEEN CONFIRMED. BD HAS IDENTIFIED A CONTAMINATION TREND FOR THIS PRODUCT AND THE INVESTIGATION FOUND OPPORTUNITIES FOR BIOBURDEN REDUCTION IN THE MANUFACTURING PROCESS. A CAPA (CORRECTIVE AND PREVENTATIVE ACTIONS) HAS BEEN INITIATED AND INVOLVES IMPLEMENTING ADDITIONAL CLEANING EVENTS AND EVALUATION OF MANUFACTURING PROCEDURES FOCUSED ON IN-PROCESS BIOBURDEN REDUCTION. ADDITIONAL TRAININGS ARE PLANNED WITH AN ONGOING TRAINING REVIEW FOR CLEANING PROCESSES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ HEKTOEN ENTERIC AGAR WAS CONTAMINATED UPON ARRIVAL. THE CONTAMINATION APPEARS TO BE BIOLOGICAL GROWTH. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED CONTAMINATION UPON ARRIVAL. THE CONTAMINATION APPEARS TO BE BIOLOGICAL GROWTH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ HEKTOEN ENTERIC AGAR WAS CONTAMINATED UPON ARRIVAL. THE CONTAMINATION APPEARS TO BE BIOLOGICAL GROWTH. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED CONTAMINATION UPON ARRIVAL. THE CONTAMINATION APPEARS TO BE BIOLOGICAL GROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2934465 BD BBL¿ HEKTOEN ENTERIC AGAR CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON, DICKINSON & CO. (SPARKS) 221366 2221363 10382902213663

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown