BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ PLATE COLUMBIA AG 5% SB 90MM 20

    MDR report key: 12721592 · Received October 29, 2021

    Report

    Report Number
    9680577-2021-00066
    Event Type
    Malfunction
    Date Received
    October 29, 2021
    Date of Event
    October 1, 2021
    Report Date
    November 27, 2021
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    KZI
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE FINDINGS ON THE RECENT COMPLAINT AGAINST BDTM COLUMBIA AGAR WITH 5 % SHEEP BLOOD, CATALOG NUMBER 254005, LOT NUMBER 1211454 WITH RESPECT TO CONTAMINATION. EVENT DESCRIPTION: IT WAS REPORTED THAT PRODUCT ARRIVED WITH CONTAMINATING MICROORGANISMS PRESENT ON THE PRODUCT. COMPLAINT HISTORY REVIEW: COMPLAINT TREND WAS ANALYZED FOR THE PAST 12 MONTHS. NO SIMILAR COMPLAINTS FOR THE AFFECTED BATCH WERE REGISTERED. FOR CATALOG NUMBER 254005 A TOTAL OF THREE COMPLAINTS REGARDING CONTAMINATION WERE REPORTED IN THE PAST 12 MONTHS. HOWEVER, A TREND COULD NOT BE DETECTED. BATCH HISTORY RECORD (BHR) REVIEW: THE BHR WAS REVIEWED. NO DEVIATIONS FROM THE VALIDATED PRODUCTION PROCESSES WERE REPORTED. DURING QC STERILITY TESTING ONE SUBLOT SHOWED AN INCREASED CONTAMINATION RATE VIOLATING INTERNAL ACCEPTANCE QUALITY LIMIT. THE AFFECTED SUBLOT WAS SCRAPPED COMPLETELY AND ALL OTHER SUBLOTS PASSED STERILITY TESTING WITHOUT DEVIATIONS. SAMPLE ANALYSIS: RETURN SAMPLES AND PICTURES WERE NOT PROVIDED BY THE CUSTOMER. RETAIN SAMPLES FOR BATCH 1211454 WERE ANALYZED. NO CONTAMINATED PLATES WERE DETECTED. EVALUATION RESULTS: SINCE THE BHR SHOWED NO DEVIATIONS WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN THE MANUFACTURING PROCESS. RETAIN SAMPLES SHOWED NO SIGN OF CONTAMINATION. FURTHER EVALUATION AND INVESTIGATION WAS NOT POSSIBLE SINCE NO PICTURE SAMPLES WERE PROVIDED. THEREFORE, THIS COMPLAINT CANNOT BE CONFIRMED. HOWEVER, BD WILL CONTINUE TO MONITOR ALL INCOMING COMPLAIN FOR SIMILAR DEFECT TYPES. INVESTIGATION CONCLUSION: THE AFFECTED PRODUCT IS FILLED ASEPTICALLY. THIS RESULTS IN A RARE CHANCE FOR CONTAMINATION. THEREFORE THE PRODUCT IS TESTED FOR STERILITY DURING QC RELEASE TEST WITH AN INTERNAL ACCEPTANCE QUALITY LIMIT APPLIED. IF THE STERILITY TESTING RESULT SHOWS DEVIATIONS, ALL TESTING IS REPEATED AND AFFECTED SUBLOTS ARE SORTED OUT. THIS ENSURES THAT ALL PRODUCT RELEASED TO MARKET COMPLIES WITH OUR INTERNAL STERILITY STANDARDS FOR ASEPTICALLY FILLED PRODUCTS. THE INVESTIGATION ITSELF WAS MADE DIFFICULT BECAUSE OF THE LACK OF APPROPRIATE PICTURES. 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.

    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 AGAR WITH 5% SHEEP BLOOD CATALOG NUMBER 221165 WITH 510K NUMBER PREAMENDMENT. 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 THE BD BBL¿ PLATE COLUMBIA AG 5% SB 90MM 20 PLATES WERE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: DEAR OFFICE, AS SHOWN BY THE COMMUNICATIONS ALREADY SENT PREVIOUSLY, WE ARE FINDING THE PRESENCE OF CONTAMINATION ON SOME PRODUCTS BUT WE HAVE NOT RECEIVED ANY REPLIES OR REPLENISHMENT OF THE PACKAGES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BBL¿ PLATE COLUMBIA AG 5% SB 90MM 20 PLATES WERE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: DEAR OFFICE, AS SHOWN BY THE COMMUNICATIONS ALREADY SENT PREVIOUSLY, WE ARE FINDING THE PRESENCE OF CONTAMINATION ON SOME PRODUCTS BUT WE HAVE NOT RECEIVED ANY REPLIES OR REPLENISHMENT OF THE PACKAGES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1618812 BD BBL¿ PLATE COLUMBIA AG 5% SB 90MM 20 CULTURE MEDIA, ENRICHED KZI BECTON DICKINSON GMBH 1211454

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown