BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TRYPTICASE¿ SOY BROTH

    MDR report key: 12028745 · Received June 18, 2021

    Report

    Report Number
    1119779-2021-01015
    Event Type
    Malfunction
    Date Received
    June 18, 2021
    Date of Event
    May 13, 2021
    Report Date
    February 2, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    30382902218150
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY MATERIAL 221815 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 1070138 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING AND TORQUING PROCESSES WERE WITHIN SPECIFICATIONS. IN PROCESS CHECKS WERE PERFORMED AT THE DESIGNATED INTERVALS. THOSE CHECKS CONFIRMED THAT THE CAPS WERE TIGHTENED TO THE VALIDATED SPECIFICATIONS PER PROCEDURE. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. AS PART OF THE RELEASE CRITERIA FOR THIS PRODUCT, THE BHR IS REVIEWED TO CONFIRM THE FOLLOWING: AS PART OF THE RELEASE CRITERIA FOR THIS PRODUCT, THE BHR IS REVIEWED TO CONFIRM THE FOLLOWING: THE TOTAL ELAPSED TIME BETWEEN END OF FORMULATION AND START OF THE AUTOCLAVE CYCLE WAS WITHIN THE SPECIFIED LIMITS. ALL AUTOCLAVE PARAMETERS CONFORMED TO THE VALIDATED CYCLE PARAMETERS FOR THIS PRODUCT. THE MINIMUM F0 FOR THIS PRODUCT WAS MET. THE COMPLAINT HISTORY WAS REVIEWED, AND FOUR OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH FOR APPEARANCE. RETENTION SAMPLES FROM BATCH 1070138 WERE AVAILABLE FOR INSPECTION. THERE WAS NO OBSERVABLE EVIDENCE OF APPEARANCE DEFECTS FROM VISUAL INSPECTION OF 10/10 TUBES. THE APPEARANCE OF THE MEDIA WAS IN ACCORDANCE WITH THE CERTIFICATE OF ANALYSIS. FOR FURTHER TESTING TWO RETENTIONS WENT INTO TESTING. ONE TUBE WAS PLACE AT 20¿25-DEGREE CELSIUS INCUBATION AND ONE TUBE WAS PLACED INTO 33-37DEGREE CELSIUS INCUBATION. AT THE END OF THE INCUBATION PERIOD NO MICROBIAL GROWTH OR TURBIDITY WAS OBSERVED. NO PHOTOS WERE RECEIVED FOR THE INVESTIGATION. RETURNS WERE RECEIVED FOR THE INVESTIGATION. RECEIVED AN INSULATED SHIPPING CARTON WITH FIVE CARTONS FROM BATCH 1070138 (CARTON NUMBERS 008, 044, 036, 070, AND 024). EACH CARTON WAS THOROUGHLY INVESTIGATED. CARTON NUMBER 044 50/100 TUBES WERE RECEIVED FOR INVESTIGATION. ALL FIFTY TUBES HAD A HAZY APPEARANCE. CARTON NUMBER 024 99/100 TUBES WERE RECEIVED ALL NINETY-NINE TUBES DID APPEAR HAZY. CARTON NUMBER 036 100/100 TUBES WERE RECEIVED. ALL ONE-HUNDRED TUBES HAD A HAZY APPEARANCE. CARTON NUMBER 070 100/100 TUBES WERE RECEIVED. ALL ONE-HUNDRED TUBES HAD A TURBID APPEARANCE. CARTON NUMBER 008 99/100 TUBES WERE RECEIVED. NINETY-NINE TUBES HAD CLEAR YELLOW APPEARANCE WHICH WAS IN ACCORDANCE WITH THE CERTIFICATE OF ANALYSIS. ACCORDING TO THE CERTIFICATE ANALYSIS THE BROTH APPEARANCE SHOULD BE LIGHT YELLOW TO MEDIUM TAN-YELLOW; CLEAR TO TRACE HAZY. FOR INVESTIGATION, FOUR TUBES FROM CARTONS 008, 044, 036, 070, AND 024 WERE INCUBATED AND PLATED TO TEST FOR CONTAMINATION AND GROWTH. ONE TUBE FROM EACH CARTON WAS PLACED AT 20¿25-DEGREE CELSIUS INCUBATION AND ONE TUBE FROM EACH CARTON WAS PLACED INTO 33¿37-DEGREE CELSIUS INCUBATION. AT THE END OF THE INCUBATION PERIOD ALL INCUBATED TUBES FROM BOTH TEMPERATURES ,FROM CARTONS 044, 036, 070, AND 024, THE TUBES STILL SHOWED A HAZY SEDIMENT LIKE APPEARANCE. CARTON 008, THE TUBE APPEARANCE AT BOTH TEMPERATURES AFTER INCUBATION REMAINED YELLOW. TWO TUBES FROM EACH CARTON WERE INOCULATED ONTO TWO TSA 5% SB PLATES AND PLACED INTO INCUBATION AT 25 DEGREES AND 35 DEGREES CELSIUS TEMPERATURES FOR A SEVEN-DAY INCUBATION PERIOD. NO MICROBIAL GROWTH WAS OBSERVED ON THE PLATES. THE HAZY APPEARANCE WAS CONSISTENT IN THE TUBES POST INCUBATION AND AFTER, FROM CARTONS 044, 036, 070, AND 024. A GRAM STAIN WAS PERFORMED. THE GRAM STAIN SHOWED GRAM VARIABLE RODS. CAUTION SHOULD BE EXERCISED IN REPORTING DIRECT GRAM STAIN AND/OR OTHER DIRECT MICROBIOLOGICAL STAIN RESULTS ON TISSUE SPECIMENS PROCESSED WITH THIS MEDIUM DUE TO THE POSSIBLE PRESENCE OF NONVIABLE ORGANISMS IN THE CULTURE MEDIUM. CULTURE MEDIA SOMETIMES CONTAIN DEAD ORGANISMS DERIVED FROM MEDIUM CONSTITUENTS, WHICH MAY BE VISIBLE IN SMEARS OF CULTURE MEDIA. OTHER SOURCES OF DEAD ORGANISMS VISIBLE UPON GRAM STAINING INCLUDE STAINING REAGENTS, IMMERSION OIL, GLASS SLIDES, AND THE SPECIMENS USED FOR INOCULATION. IF THERE IS UNCERTAINTY ABOUT THE VALIDITY OF THE GRAM STAIN, THE CULTURE SHOULD BE REINCUBATED FOR ANOTHER HOUR OR TWO AND THE TEST REPEATED BEFORE A REPORT IS GIVEN A TREND HAS NOT BEEN IDENTIFIED, THEREFORE, NO ACTIONS ARE PLANNED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR APPEARANCE AND NON-VIABLES. THIS COMPLAINT CAN BE CONFIRMED FROM THE RETURNS FOR APPEARANCE AND NON-VIABLES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 5 BD BBL¿ TRYPTICASE¿ SOY BROTH NON-VIABLE CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER PROBLEM: CUSTOMER REPORTS GRAM VARIABLE RODS IN FLUID. CUSTOMER INSERTS SWABS INTO BROTH AND VORTEXES OUT FOR GROWTH. THERE CAN BE SEEN A LIGHT HAZINESS THAT HAS SETTLED OUT AT BOTTOM OF TUBE CUSTOMER BELIEVES TO BE NON-VIABLE ORGANISMS."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING 5 BD BBL¿ TRYPTICASE¿ SOY BROTH NON-VIABLE CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " ¿ CUSTOMER PROBLEM: CUSTOMER REPORTS GRAM VARIABLE RODS IN FLUID. CUSTOMER INSERTS SWABS INTO BROTH AND VORTEXES OUT FOR GROWTH. THERE CAN BE SEEN A LIGHT HAZINESS THAT HAS SETTLED OUT AT BOTTOM OF TUBE CUSTOMER BELIEVES TO BE NON-VIABLE ORGANISMS. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921705 BD BBL¿ TRYPTICASE¿ SOY BROTH CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 221815 1070138 30382902218150

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown