BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOTTLE COLUMBIA BROTH 500G

    MDR report key: 22479643 · Received July 11, 2025

    Report

    Report Number
    1119779-2025-01742
    Event Type
    Malfunction
    Date Received
    July 11, 2025
    Date of Event
    June 12, 2025
    Report Date
    October 2, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    PPM
    UDI-DI
    00382902944201
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY - THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR COMPLAINT RELATED TO BOTTLE COLUMBIA BROTH 500G, CATALOG NUMBER 294420, BATCH 4220587, COMPLAINT #(B)(4) FOR PERFORMANCE. COMPONENTS ARE MILLED AND BLENDED (WHERE REQUIRED) AND DISPENSED INTO CONTAINERS. FOLLOWING QC RELEASE, AND BASED UPON INVENTORY DEMAND, FINAL PACKAGING OPERATIONS OCCUR, WHICH INCLUDE DISPENSING INTO AND LABELING OF FINAL CONFIGURATIONS, FOLLOWED BY TRANSPORT TO THE DISTRIBUTION CENTER. THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF THE BATCH HISTORY RECORD. THE BATCH HISTORY RECORD REVIEW INDICATED NO DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY. RELEASE TESTING INCLUDES DEHYDRATED MEDIUM APPEARANCE, SOLUBILITY, SOLUTION APPEARANCE, PH, AND GROWTH PERFORMANCE WITH ORGANISMS AS SPECIFIED ON THE BD CERTIFICATE OF ANALYSIS. THE COMPLAINT TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS. DURING THAT TIME THERE HAVE BEEN NO OTHER COMPLAINTS ABOUT THIS PRODUCT. NO RETURNS WERE RECEIVED. ONE PHOTO WAS RECEIVED WITH THE COMPLAINT. THE PHOTO SHOWS THREE BOTTLES OF DIFCO COLUMBIA BROTH REF 294420, LOT 4220587, EXP. 2029-06-30. DIGITAL TEXT WAS PLACED ABOVE THE BOTTLE LABELS AND READS ¿LOT NUMBER PURCHASED IN 2025. BACTERIAL LINES DO NOT GROW ON THIS MEDIA¿. THE COMPLAINT STATES THAT THE MEDIA WON¿T GROW BACTERIAL LINES. AS THIS IS A BROTH MEDIUM, MOST BACTERIAL GROWTH WILL BE CONFIRMED BY HAZE OR TURBIDITY IN THE LIQUID. WITHOUT SPECIFIC CULTURE INFORMATION NO FURTHER INVESTIGATION COULD BE CONDUCTED AT THIS TIME. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND DCM COMPLAINTS FOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED AFTER PREPARING CULTURE PLATES USING ONE BOTTLE COLUMBIA BROTH 500G, THE MEDIA DID NOT GROW BACTERIAL LINES AFTER BEING INOCULATED AND INCUBATED. NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED AFTER PREPARING CULTURE PLATES USING ONE BOTTLE COLUMBIA BROTH 500G, THE MEDIA DID NOT GROW BACTERIAL LINES AFTER BEING INOCULATED AND INCUBATED. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677555 BOTTLE COLUMBIA BROTH 500G GENERAL PURPOSE REAGENT PPM BECTON DICKINSON & CO. (SPARKS) 4220587 00382902944201

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown