BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLATE COLUMBIA AG 5PRCT SB 90MM

    MDR report key: 12980755 · Received December 10, 2021

    Report

    Report Number
    9680577-2021-00093
    Event Type
    Malfunction
    Date Received
    December 10, 2021
    Date of Event
    November 8, 2021
    Report Date
    March 1, 2022
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    KZI
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE FINDINGS ON TH RECENT COMPLAINT AGAINST BDTM COLUMBIA AGAR WITH 5 % SHEEP BLOOD, CATALOG NUMBER 254071, LOT NUMBER 1243759 WITH RESPECT TO CONTAMINATION. EVENT DESCRIPTION: PLATES OF LOT 1243759 WERE FOUND TO BE CONTAMINATED. COMPLAINT HISTORY REVIEW: THE COMPLAINT TREND WAS REVIEWED FOR A PERIOD COVERING 12 MONTHS. THE AMOUNT OF REGISTERED COMPLAINTS REGARDING CONTAMINATION OF LOT 1243759 REACHED AN INTERNAL ACTION LIMIT. A TREND COULD BE IDENTIFIED. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY REVIEW DID NOT INDICATE ANY DISCREPANCIES FROM VALIDATED PRODUCTION PROCESSES. HOWEVER, QC RELEASE TESTING OF ONE SUBLOT FOR LOT 1243759 SHOWED SUBLIMINAL CONTAMINATION. THE INTERNAL ACCEPTANCE QUALITY LIMIT (AQL) FOR STERILITY WAS NOT VIOLATED. SAMPLE ANALYSIS: RETURN SAMPLES WERE NOT PROVIDED BY THE CUSTOMER. PICTURE SAMPLES, PROVIDED BY THE CUSTOMER, SHOW PLATES WITH VISIBLE MICROBIAL GROWTH PRESENT. RETAIN SAMPLES OF LOT 1243759 WERE ANALYZED AND SHOWED NO SIGN OF CONTAMINATION. EVALUATION RESULTS: BASED ON THE INTERNAL INVESTIGATION AND THE PICTURE SAMPLES PROVIDED, THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION. IN ADDITION, A COMPLAINT TREND FOR CATALOG NUMBER 254071 WAS IDENTIFIED. THEREFORE, AN INTERNAL TEAM WAS FORMED FOR INVESTIGATION PURPOSES. A DEFINITE ROOT CAUSE COULD NOT BE IDENTIFIED. WE ARE SORRY FOR THE INCONVENIENCE. INVESTIGATION CONCLUSION: ASEPTIC MANUFACTURING PROCESSES ARE UNABLE TO GUARANTEE STERILITY OF THE PRODUCT. SINCE A 100 % INSPECTION IS NOT POSSIBLE FOR ASEPTIC PRODUCTS, STERILITY TESTING CARRIED OUT ON THE BASIS OF A REPRESENTATIVE SAMPLE. THEREFORE, OCCASIONAL CONTAMINATION CANNOT BE PREVENTED. HOWEVER, A TREND WAS IDENTIFIED. A TEAM WAS FORMED TO IMPROVE INTERNAL PROCESSES AND REDUCE THE OCCURRENCE RATE OF SUBLIMINAL CONTAMINATION. EFFECTIVENESS CHECKS INDICATE A SIGNIFICANT IMPROVEMENT TO THE SITUATION CAUSED BY THE TRIGGERED ACTIONS. BD WILL CONTINUE TO MONITOR INCOMING COMPLAINTS FOR SIMILAR DEFECT TYPES. 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

    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¿ COLUMBIA 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 BD 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: "CONTAMINATED AGAR PLATES ".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD 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: "CONTAMINATED AGAR PLATES ".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1877456 BD PLATE COLUMBIA AG 5PRCT SB 90MM CULTURE MEDIA, ENRICHED KZI BECTON DICKINSON GMBH 1243759

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown