BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TRYPTICASE¿ SOY BROTH

    MDR report key: 12097000 · Received June 30, 2021

    Report

    Report Number
    1119779-2021-01097
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    June 2, 2021
    Report Date
    February 4, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-06-11. 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 THREE OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH FOR CONTAMINATION. RETENTION SAMPLES FROM BATCH 1070138 (10 TUBES) WERE AVAILABLE FOR INSPECTION. THERE WAS NO OBSERVABLE EVIDENCE OF SEDIMENTATION OR TURBIDITY FROM VISUAL INSPECTION OF 10/10 TUBES. FOR FURTHER TESTING, TWO RETENTIONS TUBES WERE INCUBATED. ONE RETENTION TUBE WAS PLACED IN A 20 TO 25 DEGREES C INCUBATOR AND ONE RETENTION TUBE WAS PLACED INTO A 33 TO 37 DEGREES C INCUBATOR. AT THE SEVEN DAYS INCUBATION, NO MICROBIAL GROWTH OR SEDIMENTATION WAS OBSERVED IN 2/2 RETENTION TUBES. SIX PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION: THE FIRST PHOTO SHOWS THE TOP OF A 100PACK CARTON TUBE RACK WITH 94 TUBES IN THE RACK. THE SECOND PHOTO SHOWS A CLOSE-UP OF TUBE LABELS FROM BATCH 1070138 FOR BATCH VERIFICATION. THE THIRD AND FOURTH PHOTO EACH SHOW THE BOTTOM OF FIVE TUBES TO FEATURE THE MEDIA. NO MICROBIAL GROWTH CAN BE SEEN IN THE MEDIA IN THE PHOTOS. THE FIFTH PHOTO SHOWS A CARTON LABEL FROM BATCH 1070138 (CARTON NUMBER 189). RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. A TOTAL OF 94 TUBES FROM BATCH 1070138 WERE RETURNED IN A SHIPPING BOX. NO VISIBLE EVIDENCE OF CONTAMINATION WAS OBSERVED IN 94/49 RETURNED TUBES. FOR FURTHER TESTING, TWO RETURN TUBES WERE INCUBATED. ONE TUBE WAS PLACED IN A 20 TO 25 DEGREES C INCUBATOR AND ONE TUBE WAS PLACED INTO A 33 TO 37 DEGREES C INCUBATOR. AT THE SEVEN DAYS INCUBATION, NO MICROBIAL GROWTH WAS OBSERVED IN 2/2 RETURNED TUBES. THIS COMPLAINT CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 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: "UPON UNPACKING, THE CUSTOMER FOUND THAT THE MEDIA WERE CONTAMINATED WITH BACTERIA."

    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 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: "UPON UNPACKING, THE CUSTOMER FOUND THAT THE MEDIA WERE CONTAMINATED WITH BACTERIA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986988 BD BBL¿ TRYPTICASE¿ SOY BROTH CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 1070138

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown