BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TRYPTICASE¿ SOY BROTH

    MDR report key: 16134373 · Received January 10, 2023

    Report

    Report Number
    1119779-2023-00013
    Event Type
    Malfunction
    Date Received
    January 10, 2023
    Date of Event
    October 5, 2022
    Report Date
    January 6, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    30382902973547
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS REGARDING THE COMPLAINT RELATED TO CATALOG NUMBER 297354, TUBE TRYPTICASE SOY BROTH 10 ML 100 EA, BATCH NUMBER 2062203 AND BD COMPLAINT NUMBER 6281246 FOR SEDIMENTATION. MATERIAL 297354 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 REVIEWS FOR BATCH 2062203 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. IN PROCESS CHECKS ARE PERFORMED DURING MANUFACTURING AT DESIGNATED INTERVALS PER PROCEDURES. THOSE CHECKS CONFIRMED THAT THE CAPS WERE TIGHTENED TO THE VALIDATED SPECIFICATIONS PER INTERNAL PROCEDURE AND FILL VOLUMES WERE WITHIN SPECIFICATION. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. AS PART OF THE RELEASE CRITERIA FOR THIS PRODUCT THE BHRS ARE 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 OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH FOR CONTAMINATION. RETENTION SAMPLES FROM BATCH 2062203 (10 TUBES) WERE AVAILABLE FOR INSPECTION. NO MEDIA DEFECTS SUCH AS TURBID MEDIA OR SEDIMENTATION WERE OBSERVED IN 10/10 RETENTION SAMPLES FROM VISUAL INSPECTION. FOR INVESTIGATION OF THE COMPLAINT, RETENTION SAMPLES WERE TESTED. RETENTION TUBES WERE INCUBATED AT 20 TO 25 DEGREES C (1 TUBE) AND 33 TO 37 DEGREES C (1 TUBE). AT SEVEN DAYS INCUBATION, TUBES WERE INSPECTED AND NEITHER RETENTION TUBE HAD MICROBIAL GROWTH OR CHANGE IN MEDIA APPEARANCE. TWO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THE FIRST PHOTO SHOWS THE LABEL OF A TUBE FROM BATCH 2062203 FOR BATCH VERIFICATION. THE OTHER PHOTO SHOWS A CLOSE UP OF THE MEDIA OF TWO TUBES WITH WHAT APPEARS TO BE SEDIMENTATION IN BOTH TUBES. NO RETURNS WERE RECEIVED FOR INVESTIGATION. RETURN SAMPLES FROM OTHER COMPLAINTS FOR BATCH 2062203 WHICH HAVE SHOWN SIMILAR SEDIMENTATION WERE TESTED AND FOUND TO CONTAIN NON-VIABLE ORGANISMS. CAUTION SHOULD BE EXERCISED IN REPORTING DIRECT MICROBIOLOGICAL STAIN OR MOLECULAR TESTING DIRECTLY USING THIS MEDIUM DUE TO THE POSSIBLE PRESENCE OF NON-VIABLE 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. THIS MEDIA IS TERMINALLY AUTOCLAVED AFTER FORMULATION AND FILLING TO REDUCE BIOBURDEN BUT DOES NOT HAVE A STERILE CLAIM. PRODUCT SHOULD NOT BE USED IF MEDIUM SHOWS EVIDENCE OF CONTAMINATION, DISCOLORATION, DRYING OR OTHER SIGNS OF DETERIORATION. THIS COMPLAINT CAN BE CONFIRMED FOR NON-VIABLES. NO COMPLAINT TRENDS HAVE BEEN IDENTIFIED FOR NON-VIABLES IN THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR NON-VIABLES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ TRYPTICASE¿ SOY BROTH RESULTS INDICATE PARTICLE CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS NO MICROBIAL GROWTH HOWEVER RESULTS INDICATE PARTICLE CONTAMINATION. THERE IS NO DAMAGE NOTED TO THE TUBES ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192462 BD BBL¿ TRYPTICASE¿ SOY BROTH CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 297354 2062203 30382902973547

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown