BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BBL MEDIUM CULTURE 100ML TRYPTICASE SOY BROTH

    MDR report key: 11223174 · Received January 25, 2021

    Report

    Report Number
    9680577-2021-00003
    Event Type
    Malfunction
    Date Received
    January 25, 2021
    Date of Event
    January 4, 2021
    Report Date
    November 5, 2021
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 1/11/2021. H.6. INVESTIGATION: THIS MEMO IS TO SUMMARIZE FINDINGS ON THE RECENT COMPLAINT (B)(4) FOR BBL¿ TRYPTICASE¿ SOY BROTH, BATCH NUMBER 0259640 AND CATALOG NUMBER 299107. EVENT DESCRIPTION: IT WAS REPORTED THAT ASPERGILLUS BRASILIENSIS ATCC 16404 AND CANDIDA ALBICANS ATCC 10231 WOULD NOT GROW. COMPLAINT HISTORY REVIEW: THE COMPLAINTS TRENDS WERE REVIEWED. THERE WERE NO SIMILAR COMPLAINTS RECEIVED DURING THAT PERIOD ON THIS PRODUCT LOT. THEREFORE, A TREND COULD NOT BE IDENTIFIED. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY REVIEW DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY, AND NO DEVIATIONS WERE OBSERVED. SAMPLE ANALYSIS: PICTURES WERE PROVIDED SHOWING BOTTLES AND A DESCRIPTION OF THE STRAINS USED IN THEM. ALSO, PHYSICAL SAMPLE WAS PROVIDED FOR FURTHER EVALUATION. A CONTAMINATION TEST WAS PERFORMED WITH THE RETURNED SAMPLES AND NO CONTAMINATION COULD BE DETECTED. AN ANALYSIS OF GROWTH PROMOTION FOR THE MEDIA WAS PERFORMED ON RETENTION SAMPLES. THE PERFORMANCE TESTS ON RETENTION SAMPLES OF THE ABOVE MENTIONED BATCH RESULTED IN EXCELLENT GROWTH OF THE FOLLOWING STRAINS: CANDIDA ALBICANS ATCC 10231. ASPERGILLUS BRASILIENSIS ATCC 16404. AFTER AN INCUBATION TIME OF 5 DAYS AT 22,5°C ± 2,5°C IN AEROB ATMOSPHERE. EVALUATION RESULTS: AT THIS STAGE OF OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN OUR PRODUCTION PROCESS. NO DEVIATION COULD BE FOUND DURING THE QC PERFORMANCE TEST. THE STRAIN DID GROW AS EXPECTED. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION OF THE REPORT AND BASED ON THE QC TEST RESULTS, THE COMPLAINT WAS NOT CONFIRMED. A CORRECTIVE AND PREVENTIVE ACTION WILL NOT BE IMPLEMENTED AS A TREND COULD NOT BE IDENTIFIED. WE WOULD SUGGEST THAT ANY PREPARED PLATED MEDIA BE SET ASIDE AND NOT USE, THAT DOES NOT MEET THE APPEARANCE SPECIFICATION AS IT IS DESCRIBED ON THE BD CERTIFICATE OF ANALYSIS. THIS IS CONSISTENT WITH INDUSTRY RECOMMENDATIONS FOR INSPECTION OF CULTURE MEDIA PRIOR TO USE (E.G. ¿GOOD PRACTICES FOR PHARMACEUTICAL MICROBIOLOGY LABORATORIES¿, WHO TECHNICAL REPORT SERIES, NO. 961, 2011, ANNEX 2; CHAPTER 1117 ¿MICROBIOLOGY BEST LABORATORY PRACTICES¿ THE UNITED STATES PHARMACOPEIA; AND THE DIFCO & BBL MANUAL).

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BBL MEDIUM CULTURE 100ML TRYPTICASE SOY BROTH THERE WAS INSUFFICIENT GROWTH ON MEDIA. WHEN PLATED LIQUID MEDIA TO TSA, OBTAINED PURE GROWTH. THERE WAS NO REPORT OF PATIENT IMPACT. 5 CASES WERE AFFECTED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING BBL MEDIUM CULTURE 100ML TRYPTICASE SOY BROTH THERE WAS INSUFFICIENT GROWTH ON MEDIA. WHEN PLATED LIQUID MEDIA TO TSA, OBTAINED PURE GROWTH. THERE WAS NO REPORT OF PATIENT IMPACT. 5 CASES WERE AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124360 BBL MEDIUM CULTURE 100ML TRYPTICASE SOY BROTH CULTURE MEDIA JSE BECTON DICKINSON GMBH 0259640

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown