BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD

    MDR report key: 15124928 · Received July 28, 2022

    Report

    Report Number
    9680577-2022-00085
    Event Type
    Malfunction
    Date Received
    July 28, 2022
    Date of Event
    July 5, 2022
    Report Date
    August 10, 2022
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSJ
    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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED AS A DEFAULT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6 INVESTIGATION SUMMARY : THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR RECENT COMPLAINT (B)(4) AGAINST COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD, CATALOG NUMBER 254007, LOT NUMBER 2129287. EVENT DESCRIPTION: THE CUSTOMER REPORTED SEVERAL PLATES BEING NOT SELECTIVE FOR GRAM POSITIVE BACTERIA, AS GROWTH, SOMETIMES EVEN CONSIDERABLE, OF GRAM NEGATIVE BACTERIA HAS OCCURRED ON THEM. COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY HAS BEEN REVIEWED FOR A PERIOD OF 12 MONTHS AND NO SIMILAR ISSUE WAS REPORTED FOR THIS CATALOG NUMBER. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY HAS BEEN REVIEWED AND NO DEVIATION WAS RECORDED. ALL THE RELEASE TESTING WAS SATISFACTORY. SAMPLE ANALYSIS: A PERFORMANCE TEST HAS BEEN CONDUCTED ON THE RETAINING SAMPLES FOR THE STRAINS THAT SHOULD BE INHIBITED (ATCC 27853 ; PS. AERUGINOSA AND ATCC 12453; PROT. MIRABILIS) WITH EXCELLENT RESULTS. THE STRAINS WERE INHIBITED. RETURN SAMPLES WERE NOT PROVIDED HOWEVER PICTURE ILLUSTRATING A PLATE WITH BACTERIAL GROWTH WAS PROVIDED. EVALUATION RESULTS: BASED UPON OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMATIC FAILURE IN OUR MANUFACTURING PROCESS. ALL THE RELEASE TESTING WAS SATISFACTORY AND ALSO THE RETEST PERFORMED ON THE RETAIN SAMPLES WITH ATCC 27853 (PS. AERUGINOSA) AND ATCC 12453 (PROT. MIRABILIS) DID NOT REVEAL ANY DEVIATION TO THE REQUIREMENT. SINCE NO TREND WAS IDENTIFIED AND NO PROCESS DEVIATION COULD BE DETECTED, NO ACTION WILL BE CONDUCTED THIS TIME. INVESTIGATION CONCLUSION: BASED ON THE ABOVE MENTIONED INVESTIGATIONS AND TESTING, WE CANNOT CONFIRM THIS COMPLAINT. HOWEVER BD WILL CONTINUE MONITORING INCOMING COMPLAINT WITH SIMILAR FAILURE MODE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD ATYPICAL GROWTH 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: "SEVERAL PLATES ARE NOT SELECTIVE FOR GRAM POSITIVE BACTERIA, AS GROWTH, SOMETIMES EVEN CONSIDERABLE, OF GRAM NEGATIVE BACTERIA HAS OCCURRED ON THEM."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD ATYPICAL GROWTH 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: "SEVERAL PLATES ARE NOT SELECTIVE FOR GRAM POSITIVE BACTERIA, AS GROWTH, SOMETIMES EVEN CONSIDERABLE, OF GRAM NEGATIVE BACTERIA HAS OCCURRED ON THEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2924523 BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL JSJ BECTON DICKINSON GMBH 2129287

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown