BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOTTLE COLUMBIA CNA AGAR BBL 500G

    MDR report key: 22698878 · Received August 4, 2025

    Report

    Report Number
    1119779-2025-02336
    Event Type
    Malfunction
    Date Received
    August 4, 2025
    Date of Event
    July 8, 2025
    Report Date
    October 6, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    PPM
    UDI-DI
    00382902121046
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 - THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR COMPLAINT RELATED TO BOTTLE COLUMBIA CNA AGAR BBL 500G, CATALOG NUMBER 212104, BATCH 4057128 AND COMPLAINT # (B)(4) FOR PERFORMANCE ISSUE. COMPONENTS ARE MILLED AND BLENDED (WHERE REQUIRED) AND DISPENSED INTO CONTAINERS. FOLLOWING QC RELEASE, AND BASED UPON INVENTORY DEMAND, FINAL PACKAGING OPERATIONS OCCUR, WHICH INCLUDE DISPENSING INTO AND LABELING OF FINAL CONFIGURATIONS, FOLLOWED BY TRANSPORT TO THE DISTRIBUTION CENTER. THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF THE BATCH HISTORY RECORD. THE BATCH HISTORY RECORD REVIEW INDICATED NO DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY. RELEASE TESTING CONSISTS OF POWDER APPEARANCE, SOLUBILITY, PREPARED BLOOD PLATE APPEARANCE, PH, AND GROWTH PROMOTION WITH ORGANISMS SPECIFIED ON THE BD CERTIFICATE OF ANALYSIS. THE COMPLAINT TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS. DURING THAT TIME, THERE HAVE BEEN NO CONFIRMED COMPLAINTS ON THIS PRODUCT. RETENTION TESTING IS NOT REQUIRED AS BD DOES NOT MAKE CLAIMS FOR THE ORGANISM IN QUESTION. NO PHOTOS OR RETURNS WERE AVAILABLE FOR INVESTIGATION. THE COMPLAINT STATES THAT THE BATCH IS GROWING SERRATIA WHICH IS A GRAM-NEGATIVE BACTERIUM. BD DOES NOT MAKE CLAIMS TO GROWTH OF SERRATIA AND HAS NO HISTORICAL DATA OF SERRATIA GROWTH ON COLUMBIA CNA AGAR THEREFORE, NO FURTHER INVESTIGATION WAS PERFORMED. COLUMBIA CNA AGAR IS MEANT FOR THE ISOLATION OF GRAM-POSITIVE ORGANISMS, HOWEVER, IT MAY OR MAY NOT COMPLETELY INHIBIT GRAM-NEGATIVE ORGANISMS. FOR EXAMPLE, ON OUR COA PROTEUS MIRABILIS, A GRAM-NEGATIVE BACTERIUM, IS ALLOWED PARTIAL TO COMPLETE INHIBITION. DURING TESTING OF THE COMPLAINT BATCH, THIS ORGANISM WAS COMPLETELY INHIBITED AT RELEASE. PARTIAL TO COMPLETE INHIBITION IS TYPICALLY DETERMINED BY A REDUCED GROWTH COMPARED TO A NON-SELECTIVE MEDIA SUCH AS TSA. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND PERFORMANCE COMPLAINTS ON DCM PRODUCTS. IF YOU HAVE FURTHER QUESTIONS, PLEASE CONTACT BD TECHNICAL SERVICES.

    Description of Event or Problem · 0

    IT WAS REPORTED AFTER USING BOTTLE COLUMBIA CNA AGAR BBL 500G TO PREPARE MEDIA PLATES FOR GRAM POSITIVE BACTERIA ISOLATION, THERE WAS UNEXPECTED GRAM NEGATIVE SERRATIA GROWTH ON THE PLATES. NO PATIENT OR USER IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED AFTER USING BOTTLE COLUMBIA CNA AGAR BBL 500G TO PREPARE MEDIA PLATES FOR GRAM POSITIVE BACTERIA ISOLATION, THERE WAS UNEXPECTED GRAM NEGATIVE SERRATIA GROWTH ON THE PLATES. NO PATIENT OR USER IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230248 BOTTLE COLUMBIA CNA AGAR BBL 500G GENERAL PURPOSE REAGENT PPM BECTON DICKINSON & CO. (SPARKS) 4057128 00382902121046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown