BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ COLUMBIA CNA AGAR W/5% SHEEP BLOOD // MACCONKEY II AGAR

    MDR report key: 17225672 · Received June 29, 2023

    Report

    Report Number
    9680577-2023-00032
    Event Type
    Malfunction
    Date Received
    June 29, 2023
    Date of Event
    June 12, 2023
    Report Date
    August 14, 2025
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSJ
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR RECENT COMPLAINT (B)(4) REGARDING BD COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD, CATALOG NUMBER 254072 AND LOT NUMBER 3094235 WITH RESPECT TO INSUFFICIENT GROWTH. EVENT DESCRIPTION: IT WAS REPORTED THAT ON CNA AGAR LOT NUMBER 3094235 THERE IS GROWTH OF STREPTOCOCCI ONLY AFTER 48 HOURS, AFTER 24 HOURS GROWTH IS ONLY VERY SMALL OR NON-EXISTENT. COMPLAINT HISTORY REVIEW: THE COMPLAINTS TRENDS WERE REVIEWED, AND SIMILAR COMPLAINTS WERE RECEIVED FOR THE SAME CATALOG NUMBER, HOWEVER. A TREND WAS NOT IDENTIFIED. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY RECORD WAS REVIEWED. NO DEVIATIONS WERE REGISTERED FROM VALIDATED MANUFACTURING PROCESSES. ALL RELEASE TESTING WAS SATISFACTORY. SAMPLE ANALYSIS: RETAIN SAMPLES WERE ANALYZED FOR THE GROWTH PROMOTING ABILITY OF THE MEDIUM. STREPTOCOCCUS STRAINS USED FOR QUALITY RELEASE TESTING OF CATALOG NUMBER 254072 AND RECOMMENDED FOR USER QUALITY CONTROL OF THE MEDIUM WERE APPLIED TO MEDIUM OF LOT NO. 3024190 (STREPTOCOCCUS PYOGENES ATCC 19615 AND STREPTOCOCCUS PNEUMONIAE ATCC 6305). ADDITIONALLY, STREPTOCOCCUS AGALACTIAE ATCC 12386 WAS TESTED. THE GROWTH OF SAID ORGANISMS WAS EXCELLENT AFTER INCUBATION FOR 18-24HOURS AT 35-37°C IN CO2 ATMOSPHERE. NEITHER RETURN NOR PICTURE SAMPLES WERE PROVIDED BY THE CUSTOMER FOR ANALYSIS. EVALUATION RESULTS: AT THIS STAGE OF OUR INVESTIGATION, SYSTEMIC FAILURES OF THE VALIDATED MANUFACTURING PROCESSES CAN BE EXCLUDED. QC RELEASE TESTING OF THE AFFECTED LOT WAS SATISFACTORY. ANALYSIS OF THE COMPLAINT HISTORY SHOWED NO TRENDING OR VIOLATION OF ACTION LIMITS. INVESTIGATION CONCLUSION: BASED ON THE RESULTS OF THE INVESTIGATION, THE COMPLAINT CANNOT BE CONFIRMED. A DEFINITE ROOT CAUSE COULD NOT BE FOUND. HOWEVER, BD WILL CONTINUE TO MONITOR INCOMING COMPLAINTS FOR SIMILAR FAILURE TYPES.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED: B5. IT WAS REPORTED WHILE USING A BD BBL¿ COLUMBIA CNA AGAR W/5% SHEEP BLOOD // MACCONKEY II AGAR, THERE WAS INSUFFICIENT GROWTH OF STREPTOCOCCI. THERE WAS NO REPORT OF PATIENT IMPACT. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023¿2025, UNDER CAPA 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BBL¿ COLUMBIA CNA AGAR W/5% SHEEP BLOOD // MACCONKEY II AGAR THAT THERE WAS A PERFORMANCE ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GROWTH OF STREPTOCOCCI ONLY AFTER 48 HOURS. AFTER 24 HOURS ONLY VERY SMALL OR NON-EXISTENT. IF THERE IS DELAYED GROWTH OF STREPTOCOCCI, THERE MAY ALSO BE DELAYED REPORTING AND RESISTANCE DETERMINATIONS, AND PATIENTS MAY BE TREATED WITH A DELAY.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING A BD BBL¿ COLUMBIA CNA AGAR W/5% SHEEP BLOOD // MACCONKEY II AGAR, THERE WAS INSUFFICIENT GROWTH OF STREPTOCOCCI. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321308 BD BBL¿ COLUMBIA CNA AGAR W/5% SHEEP BLOOD // MACCONKEY II AGAR CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL JSJ BECTON DICKINSON GMBH 3094235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown