BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL COLUMBIA AGAR WITH 5% SHEEP BLOOD

    MDR report key: 23469265 · Received November 4, 2025

    Report

    Report Number
    9680577-2025-03124
    Event Type
    Malfunction
    Date Received
    November 4, 2025
    Date of Event
    October 14, 2025
    Report Date
    December 3, 2025
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    KSI
    UDI-DI
    00382902540052
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY- THIS MEMO IS TO SUMMARIZE FINDINGS ON THE RECENT COMPLAINT AGAINST BD COLUMBIA AGAR WITH 5% SHEEP BLOOD, CATALOG NUMBER 254005, LOT NUMBER 5202659 WITH RESPECT TO CONTAMINATION. EVENT DESCRIPTION: IT WAS REPORTED THAT IN THE PAST TWO MONTHS, THEY HAVE OBSERVED SIGNIFICANT DIMORPHISM IN BACTERIA GROWN ON BLOOD AGAR PLATES, ALTHOUGH THE IDENTIFICATION AND ANTIBIOGRAM RESULTS HAVE REMAINED CONSISTENT. SUSPECTING THE CULTURE MEDIUM, THEY ALSO INOCULATED E. COLI ATCC STRAINS ONTO THE SAME PLATES AND ENCOUNTERED THE SAME ISSUE, WHICH THEY REPORTED TO US. ADDITIONALLY, MOLD CONTAMINATION WAS ALSO DETECTED ON THE SAME PLATES. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY WAS REVIEWED FOR A PERIOD OF 12 MONTHS. SIMILAR COMPLAINTS FOR CONTAMINATION WERE RECEIVED FOR THIS CATALOG, HOWEVER, FOR DIFFERENT LOT NUMBERS, AND AN INVESTIGATION IN A CROSS-FUNCTIONAL TEAM HAS BEEN CARRIED OUT. ONE OTHER COMPLAINT FOR PERFORMANCE WAS IDENTIFIED. ANOTHER LOT NUMBER WAS AFFECTED, AND A TREND WAS NOT 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: THE RETAIN SAMPLES WERE REVIEWED AND NO CONTAMINATION WAS DETECTED. ADDITIONALLY, WITHIN THE COMPLAINT INVESTIGATION, RETAINMENT SAMPLES OF LOT 5202659 WERE USED TO TEST GROWTH OF E. COLI ATCC 25922. THE PLATES WERE INCUBATED AT 35-37 C FOR 24 H UNDER CO2 CONDITIONS. GROWTH WAS OBSERVED. THE GROWTH AND THE MORPHOLOGY OF THIS STRAIN WAS WITHIN SPECIFICATION. RETURN SAMPLES WERE NOT PROVIDED BY THE CUSTOMER. PICTURES WERE PROVIDED BY THE CUSTOMER SHOWING CONTAMINATION WITH MOLD ON PLATES OF CATALOG NUMBER 254071, LOT NUMBER 5202659. ADDITIONALLY, PICTURE SAMPLES WERE SHARED TO SHOW THE DESCRIBED BACTERIAL GROWTH ON COLUMBIA WITH 5% SB PLATES. EVALUATION RESULTS: BASED ON THE INVESTIGATION, NO DEVIATION COULD BE DETECTED IN OUR VALIDATED MANUFACTURING PROCESS. NO DEVIATION COULD BE FOUND DURING THE QC RELEASE PERFORMANCE TEST AND THE PERFORMANCE TEST ON THE RETAIN SAMPLES. GROWTH OF E. COLI ACTC 25922 COULD BE DEMONSTRATED ON THE RETAINMENT SAMPLES UNDER CO2 CONDITIONS. COLONY MORPHOLOGY WAS WITHIN SPECIFICATION. DUE TO THE INDIVIDUAL GROWTH REQUIREMENTS OF CLINICAL ISOLATES, THEY MAY NOT SHOW THE SAME GROWTH PATTERN AS LABORATORY STRAINS. THIS PRODUCT DOES NOT HAVE AN SAL (STERILITY ASSURANCE LEVEL) CLAIM. IT IS FILLED ASEPTICALLY; THEREFORE, THE STERILITY OF THE FINISHED PRODUCT CANNOT BE GUARANTEED. UNFORTUNATELY, A 100 % INSPECTION LEVEL FOR STERILITY IS NOT POSSIBLE AND STERILITY TESTING IS CARRIED OUT BASED ON A REPRESENTATIVE SAMPLE. IN CONSEQUENCE, OCCASIONAL CONTAMINATION CANNOT BE PREVENTED BY 100%. A DEFINITE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, IN AN EFFORT OF CONTINUOUS IMPROVEMENT AND TO PREVENT RECURRENCE, THE ISSUE HAS BEEN TAKEN UP IN A CAPA. INVESTIGATION CONCLUSION BASED ON THE EVALUATION AND PICTURES PROVIDED, THE COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION WITH MOLD. HOWEVER, BASED ON THE EVALUATION OF RETAIN SAMPLES WE CANNOT CONFIRM THE COMPLAINT FOR PERFORMANCE ISSUE. RESULTS OF GROWTH PROMOTION TESTS WERE SATISFACTORY. COLONY MORPHOLOGY WAS AS EXPECTED AND NO DIMORPHISM WAS OBSERVED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. BD WILL CONTINUE MONITORING INCOMING SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 0

    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 WHILE USING ONE (1) BD BBL COLUMBIA AGAR WITH 5% SHEEP BLOOD PLATE FOR PATIENT SAMPLE TESTING, THERE WAS MOLD CONTAMINATION PRESENT ON THE PLATE. THE SAMPLE WAS IMMEDIATELY RETESTED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 4 OF 500.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING ONE (1) BD BBL COLUMBIA AGAR WITH 5% SHEEP BLOOD PLATE FOR PATIENT SAMPLE TESTING, THERE WAS MOLD CONTAMINATION PRESENT ON THE PLATE. THE SAMPLE WAS IMMEDIATELY RETESTED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 4 OF 500.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1587993 BD BBL COLUMBIA AGAR WITH 5% SHEEP BLOOD CULTURE MEDIA, ENRICHED KSI BECTON DICKINSON GMBH 5202659 00382902540052

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown