BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TRYPTICASE¿ SOY BROTH

    MDR report key: 17299624 · Received July 11, 2023

    Report

    Report Number
    1119779-2023-00764
    Event Type
    Malfunction
    Date Received
    July 11, 2023
    Date of Event
    June 28, 2023
    Report Date
    October 10, 2023
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    30382902218235
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: MATERIAL 221823 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 2258392 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING, AND AUTOCLAVING 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 INTERNAL PROCEDURE. QC INSPECTION AND TESTING WAS 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 NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH. RETENTION SAMPLES FROM BATCH 2258392 (10 TUBES) WERE AVAILABLE FOR INSPECTION. NO MEDIA DEFECTS WERE OBSERVED IN 10/10 RETENTION SAMPLES. ALL RETENTION TUBES HAD THE EXPECTED APPEARANCE FOR THIS PRODUCT OF LIGHT YELLOW TO MEDIUM TAN, YELLOW, TRACE HAZY TO CLEAR. FOR INVESTIGATION, TWO RETENTION TUBES WENT INTO INCUBATION. ONE RETENTION TUBE WAS PLACED INTO 20-25-DEGREES CELSIUS, AND ONE RETENTION TUBE WAS PLACED INTO 33-37-DEGREES CELSIUS. AT THE END OF A SEVEN DAY INCUBATION PERIOD NO MICROBIAL GROWTH OR CHANGE IN THE MEDIA COLOR/CLARITY WAS OBSERVED IN 2/2 INCUBATED RETENTION TUBES. NO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION/APPEARANCE DEFECTS. CAUTION SHOULD BE EXERCISED IN REPORTING DIRECT MICROBIOLOGICAL STAIN OR MOLECULAR TESTING DIRECTLY USING 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 OR DETECTIBLE BY MOLECULAR TESTING. PRODUCT SHOULD NOT BE USED IF MEDIUM SHOWS EVIDENCE OF CONTAMINATION, DISCOLORATION, DRYING OR OTHER SIGNS OF DETERIORATION.

    Additional Manufacturer Narrative · 0

    H.3. 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 BD BBL¿ TRYPTICASE¿ SOY BROTH THERE WAS BACILLUS CEREUS CONTAMINATION IN ONE TUBE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONTAMINATION WAS NOTICED AFTER INOCULATION. CONTAMINATION ID'D AS BACILLUS CEREUS GROUP USING 16S RDNA IDENTIFICATION. MEDIA WAS SUBCULTURED TO TSA, CULTURE WAS POSITIVE. GRAM STAIN PERFORMED MANUALLY."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH THERE WAS BACILLUS CEREUS CONTAMINATION IN ONE TUBE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONTAMINATION WAS NOTICED AFTER INOCULATION. CONTAMINATION ID'D AS BACILLUS CEREUS GROUP USING 16S RDNA IDENTIFICATION. MEDIA WAS SUBCULTURED TO TSA, CULTURE WAS POSITIVE. GRAM STAIN PERFORMED MANUALLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1586839 BD BBL¿ TRYPTICASE¿ SOY BROTH CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON DICKINSON & CO. (SPARKS) 221823 2258392 30382902218235

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown