BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLATE MAC CONKEY II AGAR 90MM

    MDR report key: 13624997 · Received February 28, 2022

    Report

    Report Number
    9680577-2022-00026
    Event Type
    Malfunction
    Date Received
    February 28, 2022
    Date of Event
    January 31, 2022
    Report Date
    April 13, 2022
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE FINDINGS ON THE RECENT COMPLAINT AGAINST MACCONKEY II AGAR, CATALOG NUMBER 254025, LOT NUMBER 1329739. EVENT DESCRIPTION: IT WAS REPORTED THAT 80 PLATES WERE AFFECTED FROM CONTAMINATION AND MEDIA FALLOUT. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY WAS REVIEWED AND A TREND COULD BE IDENTIFIED FOR MEDIA FALLOUT COMPLAINTS RELATED TO ONE PRODUCTION LINE. THEREFORE, A CID (CAPA INITIATION DETERMINATION) WAS CREATED. 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: RETAIN SAMPLES WERE ANALYZED AND A DEVIATION WAS NOT DETECTED. RETURN AND PICTURE SAMPLES WERE NOT PROVIDED BY THE CUSTOMER. EVALUATION RESULTS: INTERNAL EVALUATION FOR AGAR BED FALLOUT IS INCONCLUSIVE AT THE MOMENT. A DEFINITE ROOT CAUSE COULD NOT BE IDENTIFIED. HOWEVER, SINCE A TREND WAS IDENTIFIED, AN INTERNAL TEAM WAS FORMED TO PURSUE FURTHER INVESTIGATION. PLATED MEDIA FORMULATIONS CONSIST OF APPROXIMATELY 95% WATER. THEREFORE, IT IS EXPECTED THAT THERE WILL BE SOME NORMAL WATER LOSS DURING THE STORAGE AND USAGE OF THE PRODUCT, RESULTING IN MEDIA FALLOUT. THE SEVERITY OF THIS ISSUE CAN BE FURTHER INCREASED BY TEMPERATURE EXCURSIONS. A DEFINITE ROOT CAUSE COULD NOT BE IDENTIFIED. AS A TREND COULD NOT BE IDENTIFIED, NO CORRECTIVE OR PREVENTIVE ACTIONS ARE INDICATED AT THIS TIME. HOWEVER, BD WILL CONTINUE TO MONITOR INCOMING COMPLAINTS FOR THIS TYPE OF DEFECT. CATALOG NUMBER 254025 IS FILLED UNDER ASEPTIC CONDITIONS. THEREFORE, STERILITY OF THE FINISHED PRODUCT CANNOT BE GUARANTEED. UNFORTUNATELY A 100 % INSPECTION LEVEL FOR STERILITY IS NOT POSSIBLE AND STERILITY TESTING IS CARRIED OUT ON THE BASIS OF A REPRESENTATIVE SAMPLE. IN CONSEQUENCE, OCCASIONAL CONTAMINATIONS CANNOT BE PREVENTED. IN THIS CASE, THE INTERNAL AQL WAS NOT VIOLATED AND ACTION LIMITS WERE NOT REACHED. A DEFINITE ROOT CAUSE WAS NOT IDENTIFIED. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION AND THE TREND ANALYSIS FOR MEDIA FALLOUT, THE COMPLAINT WAS CONFIRMED FOR MEDIA FALLOUT. COMPLAINT TRENDING REACHED AN INTERNAL ACTION LIMIT FOR AGAR BED FALLOUT AND AN INVESTIGATION TEAM IS CURRENTLY CONDUCTING A THOROUGH INVESTIGATION. PLEASE BE AWARE THAT SUCH AN INVESTIGATION WILL TAKE TIME AND A DEFINITE ROOT CAUSE FOR AGAR BED FALLOUT CANNOT BE REPORTED YET. THE REPORTED CONTAMINATION WAS NOT CONFIRMED AS PICTURES WERE NOT PROVIDED. WE WOULD SUGGEST TO SET ASIDE, AND NOT USE, ANY PREPARED PLATED MEDIA THAT DOES NOT MEET THE APPEARANCE AND PERFORMANCE SPECIFICATION AS IT IS DESCRIBED ON THE BD CERTIFICATE OF ANALYSIS. THIS IS CONSISTENT WITH INDUSTRY RECOMMENDATIONS FOR INSPECTION OF CULTURE MEDIA PRIOR TO USE (E.G. ¿GOOD PRACTICES FOR PHARMACEUTICAL MICROBIOLOGY LABORATORIES¿, WHO TECHNICAL REPORT SERIES, NO. 961, 2011, ANNEX 2; CHAPTER <1117> ¿MICROBIOLOGY BEST LABORATORY PRACTICES¿ THE UNITED STATES PHARMACOPEIA; AND THE DIFCO & BBL MANUAL). H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MOLD WAS DISCOVERED ON 80 PLATES OF BD PLATE MAC CONKEY II AGAR 90MM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE CUSTOMER FOUND MOLD ON 80 PLATES WHEN OPENING THE PACKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MOLD WAS DISCOVERED ON 80 PLATES OF BD PLATE MAC CONKEY II AGAR 90MM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: THE CUSTOMER FOUND MOLD ON 80 PLATES WHEN OPENING THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1862892 BD PLATE MAC CONKEY II AGAR 90MM CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON DICKINSON GMBH 1329739

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown