BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ CHOCOLATE II AGAR

    MDR report key: 22843042 · Received August 19, 2025

    Report

    Report Number
    1119779-2025-03713
    Event Type
    Malfunction
    Date Received
    August 19, 2025
    Date of Event
    July 22, 2025
    Report Date
    November 19, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JTY
    UDI-DI
    10382902212673
    PMA / PMN Number
    NA
    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

    B3. DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DURING MANUFACTURING OF MATERIAL 221267, 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 REVIEW FOR BATCH 5103383 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 NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 5103383 FOR THIS DEFECT. THERE WERE NO RETENTION SAMPLES AVAILABLE FOR INVESTIGATION OF THIS COMPLAINT. A TOTAL OF TWO PHOTOS WERE SUBMITTED BY THE CUSTOMER TO SUPPORT THEIR COMPLAINT. THE OBSERVATIONS FROM EACH PHOTO ARE AS FOLLOWS: ¿ ONE PHOTO SHOWS AN OPEN (NO LID) BLOOD AGAR PLATE, FUNGAL CONTAMINATION CAN BE SEEN. THE COMPLAINT IS FOR A CHOCOLATE AGAR PRODUCT; THIS PHOTO IS NOT RELEVANT TO THE COMPLAINT. ¿ ONE PHOTO SHOWS A SINGLE CHOCOLATE AGAR PLATE; FUNGAL CONTAMINATION CAN BE SEEN ON THE SURFACE (NO BATCH DETAILS CAN BE SEEN IN THE PHOTO). NO PRODUCT RETURNS WERE PROVIDED FOR THIS INVESTIGATION. ALTHOUGH THE PHOTOS DID NOT ALLOW FOR BATCH VERIFICATION, WE HAVE CONFIRMED THE COMPLAINT BASED ON THE ACKNOWLEDGED CONTAMINATION EVENT. AS PART OF THE INVESTIGATION MANUFACTURING RECORDS¿INCLUDING EQUIPMENT LOGS, CLEANING DOCUMENTATION, AND ENVIRONMENTAL MONITORING¿RELATED TO THE PRODUCTION OF BATCH 5103383 WAS REVIEWED. NO DEFINITIVE ROOT CAUSE WAS IDENTIFIED FOR THE CONTAMINATION OBSERVED IN THIS BATCH. A REVIEW OF QUALITY NOTIFICATIONS AND COMPLAINT DATA FOR THE MANUFACTURING PLANT, WHICH INCLUDES MATERIAL 221267, REVEALED NO BATCHES OR MATERIALS EXHIBITING CONTAMINATION TRENDS DURING CALENDAR YEAR 2025. BATCH 5103383 WAS MANUFACTURED IN APRIL OF 2025, AND NO CONTAMINATION-RELATED COMPLAINT TRENDS HAVE BEEN REPORTED. WHILE THE ROOT CAUSE REMAINS UNDETERMINED, THE CONTAMINATION EVENT WAS CONFIRMED TO BE ISOLATED TO PRODUCTS SHIPPED TO BAYLOR SCOTT & WHITE RESEARCH INSTITUTE. BASED ON THE CURRENT FINDINGS NO CORRECTIVE ACTIONS ARE IDENTIFIED AT THIS TIME. BD WILL CONTINUE TO MONITOR AND TREND CONTAMINATION-RELATED COMPLAINTS TO ENSURE ONGOING PRODUCT QUALITY.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE AND DURING USE OF BD BBL¿ CHOCOLATE II AGAR, WHITE FUNGAL CONTAMINATION WAS OBSERVED. UNINOCULATED PLATES, PLATES USED FOR NON PATIENT TESTING, AND AN UNKNOWN NUMBER OF PLATES USED WITH AN UNSPECIFIED NUMBER OF PATIENT SAMPLES WERE INVOLVED. NO CONFIRMATORY TESTING WAS PERFORMED AND THE FUNGAL CONTAMINATE WAS NOT IDENTIFIED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE AND DURING USE OF BD BBL¿ CHOCOLATE II AGAR, WHITE FUNGAL CONTAMINATION WAS OBSERVED. UNINOCULATED PLATES, PLATES USED FOR NON PATIENT TESTING, AND AN UNKNOWN NUMBER OF PLATES USED WITH AN UNSPECIFIED NUMBER OF PATIENT SAMPLES WERE INVOLVED. NO CONFIRMATORY TESTING WAS PERFORMED AND THE FUNGAL CONTAMINATE WAS NOT IDENTIFIED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1394588 BD BBL¿ CHOCOLATE II AGAR CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA JTY BECTON, DICKINSON & CO. (SPARKS) 5103383 10382902212673

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown