BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL TRYPTICASE SOY BROTH

    MDR report key: 11579719 · Received March 27, 2021

    Report

    Report Number
    1119779-2021-00566
    Event Type
    Malfunction
    Date Received
    March 27, 2021
    Date of Event
    March 3, 2021
    Report Date
    September 25, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    30382902210932
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: 3/11/2021. H.6. INVESTIGATION: MATERIAL 221093 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 0364881 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING AND TORQUING PROCESSES WERE WITHIN SPECIFICATIONS. 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 ONE OTHER COMPLAINT HAS BEEN TAKEN ON THIS BATCH. RETENTION SAMPLES FROM BATCH 0364881 (10 TUBES) WERE AVAILABLE FOR INSPECTION. NO MEDIA DEFECTS OR SEDIMENTATION WERE OBSERVED IN 10/10 RETENTION SAMPLES. FOR FURTHER INVESTIGATION, ONE RETENTION TUBE WAS INCUBATED AT 33 TO 37 DEGREES CELSIUS, AND ONE RETENTION TUBE WAS INCUBATED AT 20 TO 25 DEGREES CELSIUS. BOTH TUBES SHOWED NO SIGNS OF MICROBIAL GROWTH OR SEDIMENTATION AT SEVEN DAYS OF INCUBATION. SEVEN PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION: THE FIRST PHOTO SHOWS EIGHT BD CARTON BOXES ON A SHELF. THE BATCH INFORMATION IS NOT CLEAR TO READ FROM THE PHOTO THE SECOND PHOTO SHOWS THREE TUBES HELD UP BY THE CAPS FOCUSING ON THE MEDIA. THE MEDIA IN PHOTO APPEARS CLEAR. THE BATCH INFORMATION IN THE PHOTO CAN NOT BE SEEN. THE THIRD PHOTO ALSO SHOWS THE MEDIA OF THREE TUBES. THE MEDIA APPEARS TO BE CLEAR. BATCH INFORMATION CAN NOT BE VIEWED IN THIS PHOTO. THE FOURTH PHOTO SHOWS A CLOSEUP OF TWO BD CARTONS VERIFYING BATCH 0364881. THERE WERE THREE GRAM STAIN PHOTOS RECEIVED. ALL THREE GRAM STAIN PHOTOS SHOW WHAT APPEARS TO BE NEGATIVE RODS. NO OTHER OBSERVATIONS CAN BE MADE FROM THE PHOTOS. RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THREE BD 100 PACK TUBE CARTONS (CARTON NUMBERS 190 (100 TUBES), 199 (100 TUBES), AND 201 (100 TUBES)) WERE RECEIVED IN A SHIPPING BOX WITH PACKING AIR BUBBLES. FOR INVESTIGATION, ALL THREE CARTON TUBES WERE INSPECTED FOR EVIDENCE OF SEDIMENTATION. ALL THREE CARTONS WERE FROM BATCH 0364881. THERE WERE NO OBSERVABLE DEFECTS WITH THE MEDIA (300/300 RETURN TUBES). THE RETURNS WERE ALSO INCUBATED. TWO TUBES WERE TAKEN FROM EACH CARTON AND INCUBATED FOR A TOTAL OF SEVEN DAYS. ONE TUBE FROM EACH OF THE THREE RETURN CARTONS WAS PLACED IN 33-TO-37-DEGREE CELSIUS INCUBATION. ONE TUBE FROM EACH OF THE THREE RETURN CARTONS WAS PLACED IN 20 TO 25-DEGREE CELSIUS INCUBATION. AT THE END OF A SEVEN-DAY INCUBATION PERIOD, NO MICROBIAL GROWTH OR SEDIMENTATION WAS OBSERVED. BD WILL CONTINUE TO TREND COMPLAINTS FOR SEDIMENTATION. THE COMPLAINT CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 3 BD BBL¿ TRYPTICASE¿ SOY BROTH FOREIGN MATTER 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 REPORTED THAT THERE WERE SEDIMENTS AT THE BOTTOM OF THE TUBES 221093 LOT 0364881.3 BOXES WERE INSPECTED FROM AN ORDER OF 8 BOXES (100 TUBES EACH). CUSTOMER STATED THAT A MAJORITY OF THE TUBES WERE AFFECTED. THE TECH GRAM-STAINED THE TUBES AND GRAM POSITIVE ROD WAS FOUND. "

    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 3 BD BBL¿ TRYPTICASE¿ SOY BROTH FOREIGN MATTER 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 REPORTED THAT THERE WERE SEDIMENTS AT THE BOTTOM OF THE TUBES 221093 LOT 0364881.3 BOXES WERE INSPECTED FROM AN ORDER OF 8 BOXES (100 TUBES EACH). CUSTOMER STATED THAT A MAJORITY OF THE TUBES WERE AFFECTED. THE TECH GRAM-STAINED THE TUBES AND GRAM POSITIVE ROD WAS FOUND. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476667 BD BBL TRYPTICASE SOY BROTH CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 221093 0364881 30382902210932

    Patients

    Seq Age Sex Outcome Treatment
    1