BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD

    MDR report key: 22940657 · Received September 2, 2025

    Report

    Report Number
    9680577-2025-00376
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    November 29, 2024
    Report Date
    July 10, 2025
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSJ
    UDI-DI
    30382902540077
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY THE MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR RECENT COMPLAINT (B)(4) REGARDING BD COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD, CATALOG NUMBER 254007, LOT NUMBER 4289392 WITH RESPECT TO PERFORMANCE ISSUE. EVENT DESCRIPTION: IT WAS REPORTED BY THE CUSTOMER THAT THEY CANNOT DIFFERENTIATE HEMOLYSIS ON THE AGAR. COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY FOR THE PAST 12 MONTHS WAS REVIEWED, AND NO SIMILAR COMPLAINT WAS REGISTERED FOR THIS CATALOG NUMBER. A TREND HAS NOT BEEN IDENTIFIED. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY REVIEW DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY, AND NO DEVIATIONS WERE OBSERVED. SAMPLE ANALYSIS: AN ANALYSIS OF GROWTH PROMOTION ABILITY OF THE MEDIUM TO TEST THE FUNCTIONALITY FOR THE MEDIA WAS PERFORMED ON RETENTION SAMPLES. THE EVALUATION AND GROWTH OF S. PYOGENES ATCC 19615, S. PNEUMONIAE ATCC 6305, E. FAECALIS ATCC 29212 AND S. AUREUS ATCC 25923 STRAINS USED FOR QUALITY RELEASE TESTING OF CATALOG NUMBER 254007 WERE APPLIED TO MEDIUM OF LOT NO. 4289392. PLATES WERE INCUBATED AT 35-37°C FOR 18-24 HOURS IN CO2 ATMOSPHERE. ALL STRAINS SHOWED GOOD GROWTH ACCORDING TO OUR SPECIFICATIONS. HEMOLYTIC REACTION OF ALL STRAINS WAS ALSO WITHIN SPECIFICATION. NO CUSTOMER SAMPLES OR SAMPLE PICTURES WERE AVAILABLE. EVALUATION RESULTS: AT THIS STAGE OF THE INVESTIGATION, ANY SYSTEMIC FAILURE IN THE MANUFACTURING PROCESSES CAN BE EXCLUDED. NO DEVIATION COULD BE FOUND DURING THE QC PERFORMANCE TEST DURING INITIAL RELEASE TESTING AND DURING THE RETAIN SAMPLE TESTING. GROWTH AND HEMOLYTIC REACTION OF GROWTH PROMOTION TEST WAS AS EXPECTED. SINCE NO TREND WAS IDENTIFIED, NO CORRECTIVE PREVENTIVE ACTION WILL BE IMPLEMENTED THIS TIME. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION OF THE REPORT AND ON THE RESULTS OF THE GROWTH PROMOTION TEST USING THE RETAIN SAMPLES, THE COMPLAINT CANNOT BE CONFIRMED FOR PERFORMANCE ISSUE. RESULTS OF GROWTH PROMOTION TESTS WERE SATISFACTORY. A DEFINITE ROOT CAUSE COULD NOT BE FOUND. HOWEVER, BD WILL CONTINUE TO MONITOR INCOMING COMPLAINTS FOR SIMILAR FAILURE TYPES TO DETERMINE IF FURTHER ACTIONS ARE NEEDED. THIS 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 WHILE USING BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD, HAD A SHEEN WHICH MADE IT DIFFICULT TO DIFFERENTIATE THE HEMOLYSIS REACTION OF THE MICROORGANISM. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1997140 BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL JSJ BECTON DICKINSON GMBH 4289392 30382902540077

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown