BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL COLUMBIA AGAR WITH 5% SHEEP BLOOD PLATE 100PK

    MDR report key: 22726311 · Received August 6, 2025

    Report

    Report Number
    1119779-2025-02459
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    May 8, 2024
    Report Date
    June 20, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    KZI
    UDI-DI
    10382902212635
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER ADDRESS: (B)(6). INVESTIGATION SUMMARY: DURING MANUFACTURING OF MATERIAL 221263, MEDIA IS FORMULATED AND SENT THROUGH A HIGH TEMPERATURE SHORT TIME STERILIZER TO REMOVE BIOBURDEN. THE PETRI DISHES ARE SUBJECTED TO UV RADIATION TO DECREASE BIOBURDEN. THE PETRI DISHES ARE FILLED IN A POSITIVE PRESSURE HEPA FILTERED ENVIRONMENT. THE FILLED PLATES ARE COOLED AND IMMEDIATELY WRAPPED INTO SLEEVES TO DECREASE THE INTRODUCTION OF MICROBES. SLEEVES ARE THEN PACKAGED INTO CARTONS AND THEN TRANSFERRED TO A REFRIGERATED TRUCK (2 TO 8 DEGREES C) FOR SHIPMENT TO THE DISTRIBUTOR. BD DISTRIBUTORS ARE PROVIDED WITH THE STORAGE GUIDELINES FOR THE SHIPPING AND HANDLING OF BD MEDIA OF 2 TO 8 DEGREES C IN A DARK PLACE. THE BATCH HISTORY RECORD FOR BATCH 4044761 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. ALL BATCHES ARE TESTED PRIOR TO RELEASE AND RESULTS REPORTED ON THE CERTIFICATE OF ANALYSIS WHICH CAN BE OBTAINED AT WWW.BD.COM/REGDOCS. COLUMBIA AGAR WITH 5% SHEEP BLOOD IS STABILITY TESTED BIENNIALLY FOR BIOLOGICAL PERFORMANCE TO ENSURE SATISFACTORY PERFORMANCE THROUGHOUT SHELF LIFE WITH THE ORGANISMS THAT ARE REPORTED ON THE CERTIFICATE OF ANALYSIS. ALL PERFORMANCE TESTING ON THIS BATCH WAS SATISFACTORY AT THE TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND THE ONLY OTHER COMPLAINT TAKEN ON BATCH 4044761 ALSO WAS FROM KIMS HOSPITAL, BHUBANESHWAR FOR A DIFFERENT DEFECT. RETENTION SAMPLES FROM BATCH 4044761 WERE NOT AVAILABLE FOR INSPECTION. NO RETURN SAMPLES OR PHOTOS WERE RECEIVED FOR INVESTIGATION OF THIS COMPLAINT. THIS COMPLAINT CANNOT BE CONFIRMED FOR A PERFORMANCE DEFECT. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023-2025, UNDER CAPA 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BBL COLUMBIA AGAR WITH 5% SHEEP BLOOD PLATE 100PK THAT STAPHYLOCOCCUS AND STREPTOCOCCUS WERE NOT EXHIBITING THE EXPECTED HEMOLYSIS ON THE BLOOD AGAR PLATE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1569258 BD BBL COLUMBIA AGAR WITH 5% SHEEP BLOOD PLATE 100PK CULTURE MEDIA, ENRICHED KZI BECTON, DICKINSON & CO. (SPARKS) 4044761 10382902212635

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown