BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE COLUMBIA CNA AG 5PRCT SB 90MM

    MDR report key: 17165889 · Received June 20, 2023

    Report

    Report Number
    9680577-2023-00028
    Event Type
    Malfunction
    Date Received
    June 20, 2023
    Date of Event
    June 2, 2023
    Report Date
    June 23, 2023
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSJ
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR RECENT COMPLAINT (B)(4) REGARDING BD COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD, CATALOG NUMBER 254072 AND LOT NUMBER 3101491 WITH RESPECT TO NO GROWTH. EVENT DESCRIPTION: IT WAS REPORTED THAT THE CUSTOMER HAS ONCE AGAIN EXPERIENCING GROWTH PROBLEMS WITH ANC AGAR PLATES FOR LOT 3101491. COMPLAINT HISTORY REVIEW: THE COMPLAINTS TRENDS WERE REVIEWED, AND SIMILAR COMPLAINTS WERE RECEIVED FOR THE SAME CATALOG NUMBER; HOWEVER, A TREND WAS NOT IDENTIFIED. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY RECORD WAS REVIEWED. NO DEVIATIONS WERE REGISTERED FROM VALIDATED MANUFACTURING PROCESSES. ALL RELEASE TESTING WAS SATISFACTORY. SAMPLE ANALYSIS: RETAIN SAMPLES WERE ANALYZED FOR THE GROWTH PROMOTING ABILITY OF THE MEDIUM. STRAINS USED FOR QUALITY RELEASE TESTING OF CATALOG NUMBER 254072 AND RECOMMENDED FOR USER QUALITY CONTROL OF THE MEDIUM WERE APPLIED TO MEDIUM OF LOT NO. 3101491. THE FOLLOWING STRAINS WERE TESTED: STREPTOCOCCUS PYOGENES ATCC 19615, STREPTOCOCCUS PNEUMONIAE ATCC 6305, ENTEROCOCCUS FAECALIS ATCC 29212 AND STAPHYLOCOCCUS AUREUS ATCC 25923. ADDITIONALLY, STREPTOCOCCUS AGALACTIAE ATCC 12386 AND STAPHYLOCOCCUS SAPROPHYTICUS ATCC 15305 WAS TESTED. THE GROWTH OF SAID ORGANISMS WAS EXCELLENT AFTER INCUBATION FOR 18-24HOURS AT 35-37°C IN CO2 ATMOSPHERE. RETURN SAMPLES WERE NOT SHARED HOWEVER A PICTURE ILLUSTRATING ONE PLATES WITH SMALL BACTERIAL GROWTH WAS SHARED AND A SECOND COS PLATE WITH BACTERIAL GROWTH (LIKE STAPHYLOCOCCUS SP.). EVALUATION RESULTS: AT THIS STAGE OF OUR INVESTIGATION, SYSTEMIC FAILURES OF THE VALIDATED MANUFACTURING PROCESSES CAN BE EXCLUDED. QC RELEASE TESTING OF THE AFFECTED LOT WAS SATISFACTORY. ANALYSIS OF THE COMPLAINT HISTORY SHOWED NO TRENDING OR VIOLATION OF ACTION LIMITS. INVESTIGATION CONCLUSION: BASED ON THE RESULTS OF THE INVESTIGATION, THE COMPLAINT CANNOT BE CONFIRMED. ALL ANALYSIS DONE BY THE QC DEPARTMENT YIELDED SATISFACTORY RESULTS, FURTHER INVESTIGATION WAS OMITTED. A DEFINITE ROOT CAUSE COULD NOT BE FOUND. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. G5. 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 CNA AGAR W/5% SHEEP BLOOD // MACCONKEY II AGAR, CATALOG NUMBER 221600, WHICH IS A PREAMENDMENT DEVICE. H3. 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 DURING USE WITH THE PLATE COLUMBIA CNA AG 5PRCT SB 90MM, FALSE RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE ONCE AGAIN EXPERIENCING GROWTH PROBLEMS WITH ANC AGAR PLATES (REF (B)(4) LOT 3101491). PHOTOS OF A FILE ARE ATTACHED, COMPARING THE COS AND ANC OF THE SAME PATIENT AT THE SAME INCUBATION TIME. THE IDENTIFIED GERM (STAPH HAEMOLYTICUS) IS SUPPOSED TO GROW ON THE 2 AGARS. ON MOST OF OUR SAMPLES WE MAKE AN ANC AND COS TO HAVE ONLY THE COCCI ON ANC IF OTHER GERM IN THE SAMPLE. ERRONEOUS RESULTS WERE NOT COMMUNICATED TO THE CLINICIAN NO IMPACT ON THE PATIENT BECAUSE WE WERE ABLE TO IDENTIFY THE STRAIN ON AT LEAST 1 OF THE BOXES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE PLATE COLUMBIA CNA AG 5PRCT SB 90MM, FALSE RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE ONCE AGAIN EXPERIENCING GROWTH PROBLEMS WITH ANC AGAR PLATES (REF (B)(4) LOT 3101491). PHOTOS OF A FILE ARE ATTACHED, COMPARING THE COS AND ANC OF THE SAME PATIENT AT THE SAME INCUBATION TIME. THE IDENTIFIED GERM (STAPH HAEMOLYTICUS) IS SUPPOSED TO GROW ON THE 2 AGARS. ON MOST OF OUR SAMPLES WE MAKE AN ANC AND COS TO HAVE ONLY THE COCCI ON ANC IF OTHER GERM IN THE SAMPLE. ERRONEOUS RESULTS WERE NOT COMMUNICATED TO THE CLINICIAN NO IMPACT ON THE PATIENT BECAUSE WE WERE ABLE TO IDENTIFY THE STRAIN ON AT LEAST 1 OF THE BOXES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545042 PLATE COLUMBIA CNA AG 5PRCT SB 90MM CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL JSJ BECTON DICKINSON GMBH 3101491

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown