BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD

    MDR report key: 16583157 · Received March 21, 2023

    Report

    Report Number
    1119779-2023-00311
    Event Type
    Malfunction
    Date Received
    March 21, 2023
    Date of Event
    March 7, 2023
    Report Date
    March 31, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSJ
    UDI-DI
    00382904436247
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 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 254072 AND LOT NUMBER 3024190. EVENT DESCRIPTION: IT WAS REPORTED THAT ON CNA AGAR LOT NUMBER 3024190 THERE IS NO CULTURE AT ALL. (THE AGAR IS WELL SEEDED, CHECK MADE, AND THE BACTERIA FOUND ON THE COS ARE SUPPOSED TO GROW ON THIS AGAR TOO). COMPLAINT HISTORY REVIEW: THE COMPLAINTS TRENDS WERE REVIEWED. NO SIMILAR COMPLAINTS WERE RECEIVED FOR THE SAME CATALOG NUMBER. A TREND WAS NOT IDENTIFIED, THIS COMPLAINT WILL BE TREATED AS AN ISOLATED INCIDENT. 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. 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. THE GROWTH OF SAID ORGANISMS WAS EXCELLENT. RETURN SAMPLES WERE NOT SHARED HOWEVER A PICTURE ILLUSTRATING ONE PLATES WITHOUT BACTERIAL GROWTH WAS SHARED AND A SECOND COS PLATE WITH BACTERIAL GROWTH (LIKE STAPHYLOCOCCUS SP.). 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. AS NO FURTHER COMPLAINTS REGARDING THIS LOT WERE NOTICED AND ALL ANALYSIS DONE BY THE QC DEPARTMENT YIELDED SATISFACTORY RESULTS, FURTHER INVESTIGATION WAS OMITTED. A DEFINITE ROOT CAUSE COULD NOT BE FOUND. HOWEVER, BD WILL CONTINUE TO MONITOR INCOMING COMPLAINTS FOR SIMILAR FAILURE TYPES. WE ARE SORRY FOR THE INCONVENIENCE.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS. COMMON DEVICE NAME: CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US, BUT IT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED DEVICE BD COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD, CATALOG NUMBER 221353 WITH 510K # PREAMENDMENT. UNIQUE IDENTIFIER (UDI) #: (B)(4). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD THAT THERE WAS A PERFORMANCE ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE AGAIN PROBLEMS WITH YOUR CNA AGARS REF (B)(4). IN ATTACHMENT 2 PHOTOS OF THE SAME FILE: - COS AGAR WHERE THERE ARE MANY BACTERIA. - CNA AGAR WHERE THERE IS NO CULTURE AT ALL. (THE AGAR IS WELL SEEDED, CHECK MADE, AND THE BACTERIA FOUND ON THE COS ARE SUPPOSED TO GROW ON THIS AGAR TOO). OTHER AGARS ARE AFFECTED. LOT NUMBER 3024190.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD THAT THERE WAS A PERFORMANCE ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE AGAIN PROBLEMS WITH YOUR CNA AGARS REF 254072. IN ATTACHMENT 2 PHOTOS OF THE SAME FILE: COS AGAR WHERE THERE ARE MANY BACTERIA. CNA AGAR WHERE THERE IS NO CULTURE AT ALL. (THE AGAR IS WELL SEEDED, CHECK MADE, AND THE BACTERIA FOUND ON THE COS ARE SUPPOSED TO GROW ON THIS AGAR TOO). OTHER AGARS ARE AFFECTED. LOT NUMBER 3024190.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11555 BD COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD SEE H.10 JSJ BECTON, DICKINSON & CO. (SPARKS) 443624 3024190 00382904436247

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown