BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD

    MDR report key: 14317501 · Received May 7, 2022

    Report

    Report Number
    9680577-2022-00065
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    March 2, 2022
    Report Date
    May 5, 2022
    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

    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. INVESTIGATION CONCLUSION: BASED UPON OUR INVESTIGATION THE COMPLAINT WAS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 720 BD¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD PLATES WERE FOUND CONTAMINATED WITH BACTERIAL COLONIES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: CUSTOMER RECEIVED IN TWO DELIVERIES 1440 PLATES FROM 257306 LOT 2233567 AND AT LEAST 720 PLATES WERE GROWN WITH MIKROKOKKEN AS IT LOOKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1078235 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