BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD COLUMBIA III AGAR WITH 5% SHEEP BLOOD, PLATE, 90 MM X 20

    MDR report key: 20246344 · Received September 18, 2024

    Report

    Report Number
    9680577-2024-00027
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    September 2, 2024
    Report Date
    August 14, 2025
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    KZI
    UDI-DI
    30382902540978
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: EVENT DESCRIPTION: IT WAS REPORTED BY THE CUSTOMER THAT MULTIPLE PLATES OF DIFFERENT BD PLATES CONTAMINATED WITH ASPERGILLUS VERSICOLOR WERE FOUND. COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY WAS REVIEWED FOR A 12-MONTH PERIOD, AND SIMILAR COMPLAINTS WERE IDENTIFIED FOR THIS CATALOG NUMBER; HOWEVER, A TREND WAS NOT IDENTIFIED. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY CANNOT BE REVIEWED WITHOUT A LOT NUMBER. SAMPLE ANALYSIS: RETAIN SAMPLES COULD NOT BE ANALYZED SINCE A LOT NUMBER WAS NOT PROVIDED. RETURN SAMPLES WERE NOT PROVIDED. PICTURES WERE NOT SHARED. EVALUATION SUMMARY AND INVESTIGATION CONCLUSION: IN THE ABSENCE OF A LOT NUMBER AND WITHOUT CUSTOMER SAMPLES FURTHER INVESTIGATION CANNOT BE PERFORMED. THIS PRODUCT IS FILLED UNDER ASEPTIC CONDITIONS. HOWEVER, 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%; ALTHOUGH THE CONTAMINATION RATE REMAINS BELOW THE ACCEPTANCE LEVEL. A DEFINITE ROOT CAUSE WAS NOT IDENTIFIED. IN THE ABSENCE OF A LOT NUMBER, A PICTURE SAMPLE, OR RETURN SAMPLES, THIS COMPLAINT CANNOT BE CONFIRMED FOR CONTAMINATION. BD WILL CONTINUE TO MONITOR INCOMING COMPLAINTS FOR SIMILAR DEFECT TYPES.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED: B5. IT WAS REPORTED WHILE USING BD COLUMBIA III AGAR WITH 5% SHEEP BLOOD, PLATE, 90 MM X 20, THERE WAS A FALSE RESULT DUE TO CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT. THIS SUPPLEMENTAL 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 COLUMBIA III AGAR WITH 5% SHEEP BLOOD, PLATE, 90 MM X 20 THAT THREE (3) PLATES WERE CONTAMINATED WITH ASPERGILLUS VERSICOLOR. GROWTH APPEARED IN AREAS WHERE THE SAMPLE WAS NOT INOCULATED SO IT WAS AN OBVIOUS CONTAMINANT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD COLUMBIA III AGAR WITH 5% SHEEP BLOOD, PLATE, 90 MM X 20, THERE WAS A FALSE RESULT DUE TO CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344629 BD COLUMBIA III AGAR WITH 5% SHEEP BLOOD, PLATE, 90 MM X 20 CULTURE MEDIA, ENRICHED KZI BECTON DICKINSON GMBH UNKNOWN 30382902540978

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown