BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BOTTLE BACTO PEPTONE 500G

    MDR report key: 12800528 · Received November 11, 2021

    Report

    Report Number
    1119779-2021-01806
    Event Type
    Malfunction
    Date Received
    November 11, 2021
    Date of Event
    October 14, 2021
    Report Date
    November 17, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    PPM
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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

    H6: INVESTIGATION SUMMARY THIS MEMO IS TO SUMMARIZE FINDINGS ON THE COMPLAINT RELATED TO BOTTLE BACTO PEPTONE 500G, CATALOG NUMBER 211677, BATCH 1123046, AND COMPLAINT #3779516 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 CONSISTS OF POWDER APPEARANCE, SOLUBILITY OF 2 AND 10% SOLUTIONS, 2 AND 10 % PREPARED SOLUTION APPEARANCE, RESIDUAL SOLVENTS, PH, LOSS ON DRYING, ASH, NITROGEN, AMINO NITROGEN AND GROWTH PROMOTION WITH ORGANISMS 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 ON THIS PRODUCT FOR PERFORMANCE DEFECTS. NO RETURNS OR PHOTOS WERE RECEIVED FOR THE INVESTIGATION. A RETENTION SAMPLE FROM THE COMPLAINT BATCH WAS TESTED FOR ESCHERICHIA COLI, ATCC 25922 AND STAPHYLOCOCCUS AUREUS, ATCC 25923 PERFORMANCE AGAINST A REFERENCE BATCH OF BACTO PEPTONE. FOR PERFORMANCE TESTING, THE PEPTONE SAMPLES ARE COMBINED WITH AGAR AND SALT TO PREPARE AN AGAR MEDIA PER TEST INSTRUCTIONS, THEN PH IS ADJUSTED AS NECESSARY. SAMPLES ARE THEN BOILED FOR ONE MINUTE TO DISSOLVE, AUTOCLAVED AT 121°C FOR 15 MINUTES THEN PLACED IN A 45-50°C WATERBATH TO COOL. UPON COOLING, PLATES ARE POURED AND ALLOWED TO SOLIDIFY. PLATES ARE STREAKED WITH CULTURES, 30-300 CFU PER INOCULUM THEN INCUBATED AT 33-37°C FOR 42-48 HOURS. SATISFACTORY PERFORMANCE IS GOOD RECOVERY. ALL SAMPLES WERE SATISFACTORY; RETENTION HAD COMPARABLE GROWTH AND COLONY SIZE TO THE REFERENCE FOR BOTH COA ORGANISMS. THE UNINOCULATED PLATES REMAINED NEGATIVE. PER THE CUSTOMER COMPLAINT INTAKE, GROWTH PROMOTION ISSUES ARE BEING OBSERVED WITH C. ALBICANS. THE CUSTOMER STATES THAT THE ORGANISM SHOULD REMAIN IN THE "YEAST FORM" UNDER NORMAL CONDITIONS, BUT FILAMENTATION IS OBSERVED WITH THIS ORGANISM WHEN USING LOT 1123046 OF MATERIAL 211677. BD DOES NOT MAINTAIN CLAIMS OR PERFORMANCE DATA FOR THIS ORGANISM WITH BACTO PEPTONE. CONSEQUENTLY, THIS COMPLAINT CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH 4 BD BOTTLE BACTO PEPTONE 500G THERE WAS ATYPICAL GROWTH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS ATYPICAL GROWTH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH 4 BD BOTTLE BACTO PEPTONE 500G THERE WAS ATYPICAL GROWTH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS ATYPICAL GROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1690375 BD BOTTLE BACTO PEPTONE 500G NA PPM BECTON, DICKINSON & CO. (SPARKS) 1123046

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown