BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H.10

    MDR report key: 16475778 · Received March 2, 2023

    Report

    Report Number
    1119779-2023-00208
    Event Type
    Malfunction
    Date Received
    March 2, 2023
    Date of Event
    February 17, 2023
    Report Date
    April 7, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    30382902217429
    PMA / PMN Number
    K803023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: MATERIAL 221742 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 2335050 WAS SATISFACTORY PER INTERNAL PROCEDURES. FORMULATION, FILLING, TORQUING, AND AUTOCLAVING PROCESSES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINT HAS BEEN TAKEN ON THIS BATCH FOR CAP DEFECTS. 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 2335050 (10 TUBES) WERE AVAILABLE FOR INSPECTION. NO CAP, MEDIA DEFECTS WERE OBSERVED IN 10/10 RETENTION SAMPLES. ALL RETENTIONS TUBES HAD THE EXPECTED APPEARANCE FOR THIS PRODUCT OF LIGHT TO MEDIUM LIGHT YELLOW, TRACE HAZY TO CLEAR. FOR INVESTIGATION, TWO RETENTION TUBES WENT INTO INCUBATION. ONE RETENTION TUBE WAS INCUBATED IN THE 20¿25-DEGREE CELSIUS INCUBATOR AND ONE TUBE WAS PLACED IN THE 33¿37-DEGREE CELSIUS INCUBATOR. AT THE SEVENTH DAY OF INCUBATION THERE WERE NO SIGNS OF GROWTH OR TURBIDITY OR CHANGE IN THE MEDIA COLOR AND CLARITY. ONE PHOTO WAS RECEIVED TO ASSIST WITH THE INVESTIGATION. THE PHOTO SHOWS THE BOTTOM OF A PARTIAL TUBE. THE MEDIA DOES APPEAR MEDIUM YELLOW AND HAZY. RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. A MEDIUM SHIPPING BOX WAS RECEIVED WITH SIX TUBES FROM BATCH 2335050 MEDIA APPEARS MEDIUM YELLOW AND HAZY IN ALL SIX RETURNED TUBES. ALL SIX TUBES WERE PLACED INTO INCUBATION AT 33-37-DEGREES CELSIUS. AT THE SEVEN DAY OF INCUBATION THERE WAS NO REAL CHANGE IN MEDIA COLOR AND CLARITY. NO MICROBIAL GROWTH WAS OBSERVED. A GRAM STAIN WAS PERFORMED GRAM POSITIVE RODS WERE OBSERVED UNDER THE MICROSCOPE. NO ORGANISMS WERE OBSERVED WHEN THE MEDIA WAS PLATE ON TSA 5% SHEEP BLOOD AGAR. THIS COMPLAINT CAN BE CONFIRMED FOR NONVIABLE ORGANISMS-BASED ON THE RETURN SAMPLES RECEIVED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION/APPEARANCE DEFECTS / NON-VIABLES. 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". BD HAS IDENTIFIED A COMPLAINT TREND FOR HAZY MEDIA DUE TO THE PRESENCE OF NON-VIABLES FOR THIS PRODUCT. A CAPA (CORRECTIVE AND PREVENTATIVE ACTIONS) HAS BEEN INITIATED PER BD PROCEDURES. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE BRAND NAME: BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN 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 BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN CONTAMINATION WAS FOUND. IN 8 BOXES OF PRODUCT. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES PRODUCT HAS NON VIABLE CONTAMINATION RESEMBLING A BACILLUS OR CLOSTRIDIUM.

    Description of Event or Problem · 0

    IT WAS REPORTED BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN CONTAMINATION WAS FOUND. IN 8 BOXES OF PRODUCT. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES PRODUCT HAS NON VIABLE CONTAMINATION RESEMBLING A BACILLUS OR CLOSTRIDIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1934923 SEE H.10 CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 221742 2335050 30382902217429

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown