BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE COLUMBIA AG 5PRCT SB 90MM

    MDR report key: 12080825 · Received June 28, 2021

    Report

    Report Number
    9680577-2021-00022
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    May 31, 2021
    Report Date
    October 21, 2021
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    KZI
    PMA / PMN Number
    PREAMENDMENT
    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 COLUMBIA AGAR WITH 5% SHEEP BLOOD, CATALOG NUMBER 254071, LOT NUMBER 1082404. EVENT DESCRIPTION: IT WAS REPORTED THAT 7 PLATES WERE FOUND TO BE CONTAMINATED. COMPLAINT HISTORY REVIEW: THE COMPLAINT TRENDS WERE REVIEWED. THERE WERE NO SIMILAR COMPLAINTS REPORTED DURING THAT PERIOD ON THIS LOT NUMBER. HOWEVER, A TREND COULD NOT BE IDENTIFIED. 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: PICTURE SAMPLE WAS PROVIDED SHOWING PLATES WITH CONTAMINATION. A VISUAL INSPECTION WAS PERFORMED ON THE RETENTION SAMPLE AND ONE STACK OF PLATES WERE INCUBATED. AS A RESULT OF THIS ANALYSIS NO CONTAMINATION WAS OBSERVED. 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. PLEASE NOTE THAT THE VALID STANDARD FOR THESE PRODUCTS IS DIN EN 12322 "IN VITRO DIAGNOSTIC MEDICAL DEVICES - CULTURE MEDIA FOR MICROBIOLOGY". ACCORDING TO THIS STANDARD THE CONTAMINATION RATE FOR EACH PRODUCT LOT MUST NOT EXCEED 4.9 %. FOR OUR CONTINUOUS MONITORING, WE DERIVE A CONTAMINATION RATIO FOR BELOW THIS SPECIFIED VALUE. ACCORDING TO OUR HIGH QUALITY STANDARD, 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. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION OF THE PROVIDED REPORT AND ON THE BASIS OF THE PROVIDED PICTURE, THE COMPLAINT WAS CONFIRMED. A CORRECTIVE AND PREVENTIVE ACTION WILL NOT BE IMPLEMENTED AS A TREND COULD NOT BE IDENTIFIED. WE WOULD SUGGEST TO SET ASIDE, AND NOT USE, ANY PREPARED PLATED MEDIA THAT DOES NOT MEET THE APPEARANCE 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

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. 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¿ (B)(6) AGAR WITH 5% SHEEP BLOOD CATALOG NUMBER 221263 WHICH IS A PREAMENDMENT DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PLATE COLUMBIA AG 5PRCT SB 90MM CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "7 OUT OF 140 PLATER ARE CONTAMINATED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PLATE (B)(6) AG 5PRCT SB 90MM CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "7 OUT OF 140 PLATER ARE CONTAMINATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976766 PLATE COLUMBIA AG 5PRCT SB 90MM CULTURE MEDIA, ENRICHED KZI BECTON DICKINSON GMBH 1082404

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown