BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ THIOGLYCOLLATE MEDIUM WITHOUT INDICATOR

    MDR report key: 16942646 · Received May 16, 2023

    Report

    Report Number
    1119779-2023-00565
    Event Type
    Malfunction
    Date Received
    May 16, 2023
    Date of Event
    December 8, 2022
    Report Date
    May 15, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    30382902212004
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: MATERIAL 221200, 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 2241644, WAS SATISFACTORY PER INTERNAL PROCEDURES. FORMULATION, FILLING, TORQUING, 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 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 NO OTHER COMPLAINT HAS BEEN TAKEN ON THIS BATCH. RETENTION SAMPLES FROM BATCH 2241644 (10 TUBES) WERE AVAILABLE FOR INSPECTION. THE RETENTION SAMPLES SHOWED NO MEDIA DEFECTS IN 10/10 TUBES FROM VISUAL INSPECTION. THE COLOR AND CLARITY WAS LIGHT TO MEDIUM LIGHT YELLOW, TRACE HAZY TO CLEAR, AS DESCRIBED IN THE CERTIFICATE OF ANALYSIS. FOR INVESTIGATION, TWO UNINOCULATED RETENTION TUBES WERE INCUBATED. ONE TUBE WAS PLACED IN THE 33-TO-37-DEGREE CELSIUS INCUBATOR AND ONE TUBE WAS PLACED IN THE 20-TO-25-DEGREE CELSIUS INCUBATOR. NO MICROBIAL GROWTH OR TURBIDITY OF THE MEDIA WAS SEEN IN 2/2 INCUBATED RETENTION TUBES AT SEVEN DAYS INCUBATION. THERE WAS NO CHANGE IN THE MEDIA COLOR AND CLARITY IN 2/2 INCUBATED RETENTION TUBES. NO PRODUCT PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED BASED ON RETENTION SAMPLE INVESTIGATION. CONTAMINATION WAS NOT OBSERVED IN THE RETENTION SAMPLES. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION/APPEARANCE DEFECTS. 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. ADDITIONALLY, THIS PRODUCT IS NOT LABELED STERILE. AS STATED IN OUR PACKAGE INSERT, "DO NOT USE MEDIUM IF IT SHOWS EVIDENCE OF MICROBIAL CONTAMINATION, DISCOLORATION, DRYING OR OTHER SIGNS OF DETERIORATION". H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ THIOGLYCOLLATE MEDIUM WITHOUT INDICATOR THERE WERE 3 OCCURRENCES OF POSITIVE GRAM STAIN, BUT NO GROWTH IN MEDIA THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: POSITIVE GRAM STAIN, BUT NO GROWTH IN MEDIA THESE WERE SHOWING UP ON SOME GRAM STAINS WE WERE DOING ON TISSUE CULTURES THAT WE USED THIO BROTH TO GRIND UP FOR CULTURE. BECAUSE WE SAW THE GRAM-NEGATIVE RODS IN THE GRAM STAINS ON A FEW TISSUE CULTURES, BUT NOT GROWING ON ANY MEDIA, WE QUESTIONED IF THERE WAS SOME KIND OF CONTAMINANT. WE TESTED THE TISSUE GRINDERS, THIO BROTH AND SLIDES. THE THIO BROTH WAS WHAT HAD THE CONTAMINANT OF THE NON-VIABLE GRAM-NEGATIVE RODS IN THEM. ONE WAS REPORTED ON A PRELIMINARY GRAM STAIN REPORT. AND IT WAS PROMPTLY CORRECTED/CALLED AFTERWARDS. THE OTHERS WERE NOT REPORTED IN THE RESPECTIVE PATIENTS EMR. THEY WERE ABOUT 6 CULTURES BELONGING TO 3 DIFFERENT PATIENTS. LOT #2241644.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907614 BD BBL¿ THIOGLYCOLLATE MEDIUM WITHOUT INDICATOR CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 221200 2241644 30382902212004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown