BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTO¿ TRYPTIC SOY BROTH

    MDR report key: 14493109 · Received May 25, 2022

    Report

    Report Number
    1119779-2022-00757
    Event Type
    Malfunction
    Date Received
    May 25, 2022
    Date of Event
    April 27, 2022
    Report Date
    May 19, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    PMA / PMN Number
    EXEMPT
    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

    THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR COMPLAINT RELATED TO PAIL BACTO TRYPTIC SOY BROTH 10 KG, CATALOG NUMBER 211823, BATCH 1348594, AND COMPLAINT #(B)(4) FOR UNSATISFACTORY PREPARED APPEARANCE. 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 FOR BACTO TRYPTIC SOY BROTH. THE BATCH HISTORY RECORD REVIEW INDICATED NO DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY. RELEASE TESTING INCLUDES POWDER APPEARANCE, SOLUBILITY, PREPARED SOLUTION APPEARANCE, PH, LOSS ON DRYING, AND CULTURAL RESPONSE WITH ORGANISMS AS SPECIFIED ON THE BD CERTIFICATE OF ANALYSIS. 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. NO PHOTOS OR RETURNS WERE RECEIVED FOR INVESTIGATION. NO ORGANISM OR INOCULATION METHODS WERE PROVIDED TO ASSUME THE LOW TURBIDITY WAS OBSERVED DURING A GROWTH PROMOTION TEST. THE PREPARED APPEARANCE SPECIFICATION FOR THE UNINOCULATED 3% SOLUTION IS ALLOWED TO BE LIGHT AMBER, CLEAR. THE SOLUTION APPEARANCE RESULTS FOR THIS LOT AT THE TIME OF RELEASE WERE WITHIN SPECIFICATION; LIGHT AMBER AND CLEAR. NO ADDITIONAL INVESTIGATION WAS PERFORMED. THIS COMPLAINT IS NOT CONFIRMED. BD WILL CONTINUE TO TREND ON PREPARED APPEARANCE COMPLAINTS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BACTO¿ TRYPTIC SOY BROTH THERE WAS AN ISSUE WITH THE TURBIDITY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOLLOWED UP WITH THE CUSTOMER BY EMAIL, INFORMED HER THAT ON (B)(6) 2020, WE REPLACED A SUPPLIER FOR AN INGREDIENT IN CAT # 211823 - PAIL BACTO TRYPTIC SOY BROTH 10 KG. THERE HAVE BEEN NO CHANGES TO THE FORMULATION, MANUFACTURING PROCESS OR QC RELEASE SPECIFICATIONS FOR THIS PRODUCT. CN DOCUMENT WAS ALSO PROVIDED TO THE CUSTOMER. IT WAS REPORTED BY THE CUSTOMER THAT THERE IS LOW TURBIDITY. CUSTOMER PROBLEM: TSB 211823_1348594 LOW TURBIDITY STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER OBSERVED A LOWER THAN USUAL TURBIDITY WHEN TESTING A NEW LOT (# 1348594) OF 211823 - PAIL BACTO TRYPTIC SOY BROTH 10 KG; CUSTOMER STATES THAT SHE HAS BEEN PERFORMING THIS TESTING FOR MANY YEARS, THERE WAS NO CHANGE IN THE PROCESS; CUSTOMER JUST PERFORMED THE LAST TESTING OF A PREVIOUS LOT (# 1228052), AND THE RESULTS WERE GOOD AS BEFORE; CUSTOMER SPECIFICALLY MENTIONED THAT THE ISSUE IS NOT BAD, AND THIS IS NOT A COMPLAINT; SHE DOES NOT REQUIRE AN INVESTIGATION, SHE WILL NOT BE SENDING RETURNS, AND DOES NOT WANT ANY COMPENSATION; CUSTOMER DECLINED TO SPECIFY THE ORGANISM SHE WAS USING OR ANY DETAILS ABOUT IT, SHE ONLY MENTIONED IT IS NOT AN E. COLI; DOCUMENTED THE COMPLAINT, OFFERED TO CHECK IF THERE WAS ANY CHANGE IN RAW MATERIAL BETWEEN THESE TWO LOTS, AND SEND THE ACNS FORM FOR 211823.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2203015 BD BACTO¿ TRYPTIC SOY BROTH CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 1348594

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown