BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DIFCO¿ D-GALACTOSE

    MDR report key: 17778327 · Received September 19, 2023

    Report

    Report Number
    1119779-2023-01019
    Event Type
    Malfunction
    Date Received
    September 19, 2023
    Date of Event
    August 29, 2023
    Report Date
    October 23, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3. INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS ON THE COMPLAINT RELATED TO BOTTLE D-GALACTOSE 500G, CATALOG NUMBER 216310, BATCH 3151009 FOR HIGH BIOBURDEN LEVELS. 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. RELEASE RESULTS WERE REVIEWED AND FOUND TO BE SATISFACTORY. RELEASE TESTING CONSISTS OF DEHYDRATED APPEARANCE, SOLUTION COLOR, IR, ACIDITY/ALKALINITY, BARIUM, LEAD, SULPHATED ASH, TOTAL BACTERIA COUNT, SALMONELLA/E. COLI PRESENCE, SPECIFIC ROTATION, ASSAY, RELATED SUBSTANCES, WATER, AND ENDOTOXIN AS REPORTED 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 ON THIS LOT FOR ANY DEFECTS. THE COMPLAINT INVESTIGATION INCLUDED A VERIFICATION OF THE RESULTS FOR THIS SINGLE-INGREDIENT FORMULATION AGAINST THE REQUIREMENTS DEFINED IN THE BD PURCHASE SPECIFICATION FOR THE COMPLAINT BATCH. THE MICROBIAL LOAD SPECIFICATION OF <=100 CFU/G HAD BEEN MET UPON RELEASE OF LOT 3151009. A RETEST WAS REQUESTED OF BD'S VENDOR; BIOBURDEN RETENTION SAMPLE RESULTS OBTAINED WERE 5 CFU/G AS OBTAINED BY THE VENDOR. NO RETURNS OR PHOTOS WERE RECEIVED. BD DOES NOT ACTIVELY CONTROL FOR BIOBURDEN LEVELS THROUGHOUT THE DCM MANUFACTURING PROCESS. BASED ON BD'S SUPPLIER INVESTIGATION, THE HIGH BIOBURDEN RESULT COULD NOT BE REPLICATED. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND DCM COMPLAINTS FOR BIOBURDEN. IF YOU HAVE FURTHER QUESTIONS, PLEASE CONTACT TECHNICAL SERVICES. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. 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 THAT WHILE USING BD DIFCO¿ D-GALACTOSE THAT THERE WAS A PERFORMANCE ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OOS RESULT FOR THE MICROBIAL CONTENT TEST RESULT OBTAINED TAMC: = 240 VIABLE GERMS/G (SPECIFICATION: 100 VIABLE GERMS/G) 1 BATCH AFFECTED: 1000472744 GERMS FOUND : NON-ENTEROBACTERIACEAE: PRESENT IN THE 3 TUBES OF DILUTIONS 10-1 AND IN THE 3 TUBES OF DILUTIONS 10-2 STREPTOCOCCUS SPECIES: PRESENT IN 1 DILUTION TUBE 10-1 AND IN THE 3 DILUTION TUBES 10-2.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD DIFCO¿ D-GALACTOSE THAT THERE WAS A PERFORMANCE ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OOS RESULT FOR THE MICROBIAL CONTENT TEST: RESULT OBTAINED TAMC: = 240 VIABLE GERMS/G. (SPECIFICATION: 100 VIABLE GERMS/G). 1 BATCH AFFECTED: 1000472744. GERMS FOUND : NON-ENTEROBACTERIACEAE: PRESENT IN THE 3 TUBES OF DILUTIONS 10-1 AND IN THE 3 TUBES OF DILUTIONS 10-2. STREPTOCOCCUS SPECIES: PRESENT IN 1 DILUTION TUBE 10-1 AND IN THE 3 DILUTION TUBES 10-2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1801792 BD DIFCO¿ D-GALACTOSE SUPPLEMENT, CULTURE MEDIA JSK BECTON, DICKINSON & CO. (SPARKS) 3151009

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown