BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL TRYPTICASE SOY BROTH

    MDR report key: 11952124 · Received June 7, 2021

    Report

    Report Number
    1119779-2021-00948
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    May 10, 2021
    Report Date
    August 4, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    30382902218150
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: 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: --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 TWO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH FOR CONTAMINATION. RETENTION SAMPLES FROM BATCH 1070138 WERE AVAILABLE FOR INSPECTION. THERE WAS NO OBSERVABLE EVIDENCE OF CONTAMINATION FROM VISUAL INSPECTION OF 10/10 TUBES. FOR FURTHER TESTING, TWO RETENTIONS TUBES WERE INCUBATED. ONE TUBE WAS PLACED AT 20¿25-DEGREES CELSIUS INCUBATOR AND ONE TUBE WAS PLACED INTO 33-37DEGREES CELSIUS INCUBATOR. AT THE SEVEN DAYS INCUBATION, NO MICROBIAL GROWTH WAS OBSERVED IN 2/2 TUBES. THREE PHOTOS WERE RECEIVED FOR THE INVESTIGATION IN LIEU OF RETURNS. ONE PHOTO SHOWS THREE TUBES. ONLY TWO TUBES ARE CLEARLY FROM BATCH 1070138 AND EACH TUBE HAS MEDIA THAT IS HAZY. THE THIRD TUBE IN THIS PHOTO DOES NOT APPEAR TO BE FROM BATCH 1070138 AND HAS MEDIA THAT DOES NOT APPEAR TO BE HAZY. ACCORDING TO THE CERTIFICATE OF ANALYSIS FOR THIS BATCH, THE BROTH APPEARANCE SHOULD BE LIGHT YELLOW TO MEDIUM TAN YELLOW; CLEAR TO TRACE HAZY. THE SECOND PHOTO SHOWS THE BOTTOM OF A TUBE WITH WHAT APPEARS TO BE WHITE PARTICLES AT THE BOTTOM OF THE TUBE. THE THIRD PHOTO SHOWS TWO TUBES FROM BATCH 1070138 WITH MEDIA THAT IS HAZY. THE HAZY APPEARANCE OF THE MEDIA COULD BE DUE TO MICROBIAL GROWTH AND IT IS POSSIBLE THAT MICROBIAL CELLS IN BROTH MEDIA CAN SETTLED TO THE BOTTOM OF THE TUBE (AS IN THE SECOND PICTURE). CONTAMINATION WAS NOT SEEN IN THE RETENTION SAMPLES. THE COMPLAINT CAN BE CONFIRMED BASED ON THE PHOTOS. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. THIS PRODUCT IS NOT LABELED AS STERILE. NO ACTIONS ARE PLANNED AT THIS TIME. MEDIA SHOULD BE INSPECTED PRIOR TO USE AND SHOULD NOT BE USED IF MEDIUM SHOWS EVIDENCE OF CONTAMINATION, DRYING, CRACKING OR OTHER SIGNS OF DETERIORATION. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT WHILE USING 2 BD BBL¿ TRYPTICASE¿ SOY BROTH 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: "IT WAS REPORTED THAT CONTAMINATED WITH GRAM-POSITIVE BACILLI. PROBLEM: REPORTED THE 2ML TSB TUBES THEY RECEIVED FROM LOT 1070138 ARE CONTAMINATED WITH GRAM-POSITIVE BACILLI. THEY RECEIVE 2 SP (200 TUBES) FROM LOT 1070138, EXP. 2022/09/03 AND SHE WOULD LIKE TO RECEIVE REPLACEMENT FROM ANOTHER LOT NUMBER. "

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 2 BD BBL¿ TRYPTICASE¿ SOY BROTH 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: " IT WAS REPORTED THAT CONTAMINATED WITH GRAM-POSITIVE BACILLI. ¿ PROBLEM: REPORTED THE 2ML TSB TUBES THEY RECEIVED FROM LOT 1070138 ARE CONTAMINATED WITH GRAM-POSITIVE BACILLI. THEY RECEIVE 2 SP (200 TUBES) FROM LOT 1070138, EXP. 2022/09/03 AND SHE WOULD LIKE TO RECEIVE REPLACEMENT FROM ANOTHER LOT NUMBER. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844595 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