BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN

    MDR report key: 15323633 · Received August 30, 2022

    Report

    Report Number
    1119779-2022-01153
    Event Type
    Malfunction
    Date Received
    August 30, 2022
    Date of Event
    August 12, 2022
    Report Date
    November 28, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    30382902217429
    PMA / PMN Number
    K803023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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

    H.6 INVESTIGATION SUMMARY: MATERIAL 221742 IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER, AND THOROUGHLY MIXING UNTIL A HOMOGENEOUS SOLUTION IS OBTAINED. THE TUBES ARE FILLED, CAPPED, TORQUED, AND THEN LABELED BY MACHINE PER STANDARD OPERATING PROCEDURE (SOP). THE TUBES ARE TERMINALLY AUTOCLAVED IN AN AIR OVER PRESSURE (AOP) AUTOCLAVE, PER MANUFACTURING INSTRUCTIONS, USING A VALIDATED CYCLE. POST AUTOCLAVING, TUBES ARE PACKAGED INTO FINAL SHIPPING CONFIGURATIONS. THE BATCH HISTORY RECORD REVIEW FOR BATCH 1322739 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING, TORQUEING, AND AUTOCLAVING PROCESSES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINT HAS BEEN TAKEN ON THIS BATCH. RETENTION SAMPLES FROM BATCH 1322739 (10 TUBES) WERE AVAILABLE FOR INSPECTION. NO MEDIA DEFECTS OR EVIDENCE OF CONTAMINATION OR TURBIDITY WAS OBSERVED IN 10/10 RETENTION SAMPLES. FOR FURTHER INVESTIGATION TWO RETENTION TUBES WENT INTO INCUBATION. ONE TUBE WAS PLACED INTO 20-25-DEGREE CELSIUS, AND ONE TUBE WENT INTO 33-37-DEGREE CELSIUS INCUBATION. AT THE END OF A SEVEN-DAY INCUBATION PERIOD NO CONTAMINATION/TURBIDITY WAS OBSERVED IN 2/2 INCUBATED RETENTION TUBES. THE TUBES WERE ALSO PLATED ON TO TWO TSA 5% SHEEP BLOOD AGAR PLATES. ONE PLATE WAS INCUBATED AT 20-25 DEGREES CELSIUS AND ONE PLATE WAS INCUBATED AT 33-37 DEGREES CELSIUS. NO MICROBIAL GROWTH WAS OBSERVED ON EITHER PLATE. NO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. RETURNS WERE RECEIVED IN A SHIPPING BOX WITH TISSUE PAPER. FOUR TUBES WERE RECEIVED IN GOOD CONDITION. ALL FOUR TUBES WERE INDIVIDUALLY WRAPPED. TWO TUBES WERE FROM BATCH 1322739 AND TWO TUBES WERE FROM BATCH 2117504. THE MEDIA ON ALL FOUR TUBES DID APPEAR HAZY. PER PROCEDURE FOR MATERIAL 221742, THE BROTH IS TO BE BOILED WITH THE CAPS LOOSENED FOR TEN MINUTES. FOR FURTHER INVESTIGATION, THE FOUR RETURNED TUBES WERE BOILED FOR 10 MINUTES. THE MEDIA CLEARED TO A CLEAR MEDIUM YELLOW AS DESCRIBED IN THE CERTIFICATE OF ANALYSIS. ONE RETURNED TUBE FROM BATCH 1322739 AND ONE RETURNED TUBE FROM BATCH 2117504 WERE ALSO PLATED ON TSA 5% SHEEP BLOOD AGAR. THE PLATES WERE PLACED INTO 33-37-DEGREES CELSIUS. THE OTHER TWO RETURNED TUBES WERE INCUBATED AT 33-37-DEGREES CELSIUS. AFTER A 7-DAY INCUBATED PERIOD, NO MICROBIAL GROWTH WAS OBSERVED IN EITHER INCUBATED RETURNED TUBE AND NO MICROBIAL GROWTH WAS OBSERVED ON EITHER PLATE. THE COMPLAINT CANNOT BE CONFIRMED BASED ON EVIDENCE PROVIDED FROM THE RETURNED SAMPLE INVESTIGATION FOR BATCH 1322739. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. NO ADDITIONAL ACTIONS ARE INDICATED AT THIS TIME. NOTES RISK MANAGEMENT REVIEW INDICATES THE POTENTIAL RISK OF THE DEFECT REPORTED WAS ASSESSED AS SEVERITY [S1], PER [BALTRMTERMINALGPAPH ], REV [02], ID [18.0]. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN, LOT: 1322739 NOTED THAT ABOUT HALF OF THE BOX WAS A LITTLE FUZZY PLATED AND NO GROWTH. THERE WAS ONE OCCURRENCE IN THIS EVENT WITH NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: "IT WAS REPORTED BY THE CUSTOMER INSIDE LOT: 1322739 NOTED THAT ABOUT HALF OF THE BOX WAS A LITTLE FUZZY. PLATED AND NO GROWTH. INCUBATED AT 37C FOR 48 HOURS AND IT WAS MORE FUZZIER/CLOUDY. NO GRAM STAIN PERFORMED. "

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN, LOT 1322739 NOTED THAT ABOUT HALF OF THE BOX WAS A LITTLE FUZZY PLATED AND NO GROWTH. THERE WAS ONE OCCURRENCE IN THIS EVENT WITH NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: "IT WAS REPORTED BY THE CUSTOMER INSIDE LOT 1322739 NOTED THAT ABOUT HALF OF THE BOX WAS A LITTLE FUZZY. PLATED AND NO GROWTH. INCUBATED AT 37C FOR 48 HOURS AND IT WAS MORE FUZZIER/CLOUDY. NO GRAM STAIN PERFORMED. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132084 BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 221742 1322739 30382902217429

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown