BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD

    MDR report key: 22844025 · Received August 19, 2025

    Report

    Report Number
    1119779-2025-03715
    Event Type
    Malfunction
    Date Received
    August 19, 2025
    Date of Event
    July 22, 2025
    Report Date
    November 14, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSJ
    UDI-DI
    10382902213533
    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 221353, 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 5107162 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. A REVIEW OF QUALITY NOTIFICATIONS AND COMPLAINT DATA FOR THE MANUFACTURING PLANT, WHICH INCLUDES MATERIAL 221353, REVEALED NO BATCHES OR MATERIALS EXHIBITING CONTAMINATION TRENDS DURING CALENDAR YEAR 2025. BATCH 5107162 WAS MANUFACTURED IN APRIL OF 2025, AND NO CONTAMINATION-RELATED COMPLAINT TRENDS HAVE BEEN REPORTED. 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 5107162 FOR THIS DEFECT. THERE WERE NO RETENTION SAMPLES AVAILABLE FOR INVESTIGATION OF THIS COMPLAINT. A TOTAL OF THREE PHOTOS WERE SUBMITTED BY THE CUSTOMER TO SUPPORT THEIR COMPLAINT. THE OBSERVATIONS FROM EACH PHOTO ARE AS FOLLOWS: ONE PHOTO SHOWS A SINGLE SLEEVE FROM BATCH 5107162 (THE SLEEVE LABEL IS VISIBLE). THE SLEEVE IS TORN OPEN AND MOISTURE CAN BE SEEN FORMING ON THE INSIDE. ONE PHOTO SHOWS A SINGLE PLATE FROM BATCH 5107162 (PLATE PRINT IS VISIBLE) FACE DOWN, CONTAMINATION CAN BE SEEN. ONE PHOTO SHOWS A SINGLE SLEEVE FROM BATCH 5107162 (THE SLEEVE LABEL IS VISIBLE). NO RETURNS WERE PROVIDED FOR THIS INVESTIGATION. THIS COMPLAINT CAN BE CONFIRMED BASED ON THE PHOTOS PROVIDED. AS PART OF THE INVESTIGATION MANUFACTURING RECORDS¿INCLUDING EQUIPMENT LOGS, CLEANING DOCUMENTATION, AND ENVIRONMENTAL MONITORING¿RELATED TO THE PRODUCTION OF BATCH 5107162 WAS REVIEWED. NO DEFINITIVE ROOT CAUSE WAS IDENTIFIED FOR THE CONTAMINATION OBSERVED IN THIS BATCH. 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¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD, 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¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD, 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
    1395091 BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL JSJ BECTON, DICKINSON & CO. (SPARKS) 5107162 10382902213533

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown