BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD

    MDR report key: 14120645 · Received April 15, 2022

    Report

    Report Number
    9680577-2022-00060
    Event Type
    Malfunction
    Date Received
    April 15, 2022
    Date of Event
    March 22, 2022
    Report Date
    April 14, 2022
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSJ
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US BUT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED DEVICE BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD CATALOG NUMBER 221353 WITH 510K NUMBER PREAMENDMENT. INVESTIGATION SUMMARY: COMPLAINT HISTORY REVIEW: THE COMPLAINT TRENDS WERE REVIEWED AND SIMILAR COMPLAINTS WERE FOUND FOR THIS LOT NUMBER. THEREFORE, A MRB (MATERIAL REVIEW BOARD) WAS PERFORMED AND THIS ISSUE WILL BE INVESTIGATED WITHIN A CAPA (CORRECTIVE AND PREVENTIVE ACTION). 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: PICTURES WERE PROVIDED SHOWING THE REPORTED CONTAMINATION. THE RETENTION SAMPLES WERE REVIEWED AND THE PLATES WERE FOUND TO BE WITHOUT DEVIATION. EVALUATION RESULTS: AT THIS STAGE OF OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN OUR MANUFACTURING PROCESS. PLEASE NOTE THAT THIS PRODUCT DOES NOT HAVE AN SAL CLAIM. IT IS FILLED ASEPTICALLY, THEREFORE AN OCCURRENCE OF A CONTAMINATION EVENT CANNOT BE ENTIRELY RULED OUT. WE ONLY RELEASE PRODUCT BATCHES TO THE MARKET WITH AN AQL (ACCEPTABLE QUALITY LEVEL) = 1.5. ALTHOUGH THIS CONTAMINATION LEVEL IS VERY LOW, WE CANNOT COMPLETELY EXCLUDE THAT A CUSTOMER MAY RECEIVE A CONTAMINATED PLATE. AS SEVERAL COMPLAINTS WERE REPORTED FOR THIS PRODUCT LOT NUMBER REGARDING CONTAMINATION, A MRB (MRB 22-006) AND CAPA (# (B)(4)) WERE CREATED FOR FURTHER EVALUATION. THE ROOT CAUSE INVESTIGATION IS CURRENTLY ONGOING WITHIN THE MENTIONED CAPA # (B)(4). INVESTIGATION CONCLUSION: BASED UPON OUR INVESTIGATION THE COMPLAINT WAS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 240 BD COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD HAD BIOLOGICAL CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: CONTAMINATED PLATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173787 BD COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL JSJ BECTON DICKINSON GMBH 2033567

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown