BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TRYPTICASE¿ SOY BROTH

    MDR report key: 14758280 · Received June 21, 2022

    Report

    Report Number
    1119779-2022-00920
    Event Type
    Malfunction
    Date Received
    June 21, 2022
    Date of Event
    May 26, 2022
    Report Date
    August 19, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    30382902973547
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: 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 THREE 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 WAS OBSERVED IN 10/10 RETENTION SAMPLES FROM VISUAL INSPECTION. FOR INVESTIGATION OF THE COMPLAINT FOR CONTAMINATION/TURBIDITY THE RETENTIONS WERE TESTED. TWO RETENTION TUBES WERE INCUBATED. ONE TUBE WAS PLACED IN THE 33¿37-DEGREE CELSIUS INCUBATOR AND ONE TUBE WAS PLACED INTO THE 20¿25-DEGREE CELSIUS INCUBATOR. AT THE END OF A SEVEN-DAY INCUBATION PERIOD NEITHER RETENTION TUBE SHOWED ANY SIGNS OF MICROBIAL GROWTH OR CHANGE IN MEDIA APPEARANCE. A GRAM STAIN WAS PERFORMED ON THE RETENTION SAMPLES AND NO VIABLE ORGANISMS WERE FOUND. NO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. FIFTY-FIVE TUBES FROM BATCH 2062203 WERE RECEIVED BUBBLE WRAPPED INSIDE OF A SHIPPING BOX. ALL 55/55 TUBES APPEARED HAZY IN APPEARANCE. FOR INVESTIGATION OF THE COMPLAINT THE RETURNS WERE TESTED. ALL 55/55 RETURN TUBES WERE INCUBATED. TWENTY-EIGHT RETURN TUBES WERE PLACED IN THE 33¿37-DEGREE CELSIUS INCUBATOR AND TWENTY-SEVEN RETURN TUBES WERE PLACED INTO THE 20¿25-DEGREE CELSIUS INCUBATOR. AT THE END OF A SEVEN-DAY INCUBATION PERIOD THERE WERE NO SIGNS OF MICROBIAL GROWTH OR CHANGE IN MEDIA APPEARANCE. A GRAM-STAIN WAS ALSO PERFORMED AND NO VIABLE ORGANISMS WERE FOUND. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION/NON-VIABLE ORGANISMS. THE COMPLAINT FOR CONTAMINATION/NON-VIABLE ORGANISMS IS CONFIRMED. 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 RE-INCUBATED 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 100 TUBES OF BD BBL¿ TRYPTICASE¿ SOY BROTH WERE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING CONTAMINATION WITH THEIR 297354 TUBES FROM LOT 2062203. THEY FOUND THE CONTAMINATION DURING TESTING OF BIOLOGICAL INDICATORS. HOW MANY INDIVIDUAL TUBES DID YOU FIND TO BE CONTAMINATED?1 FULL RACK (100CT). WHEN WAS THE CONTAMINATION OBSERVED? BEFORE OR AFTER INOCULATION/INCUBATION? TURBIDITY AND THE PRESENCE OF WHAT APPEARED TO BE BACTERIAL CELLS WAS OBSERVED ON TUBES THAT HAD BEEN USED/INCUBATED FOR AN ASSAY. IT WAS LATER DISCOVERED ON THE ENTIRETY OF THE 100CT RACK THAT THEY HAD BEEN TAKEN FROM. WAS THE CONTAMINATION BIOLOGICAL IN NATURE OR FOREIGN MATTER? IT APPEARED BIOLOGICAL (BACILLI) MICROSCOPICALLY. ATTEMPTS TO ISOLATE AND CULTURE WERE UNSUCCESSFUL. IF BIOLOGICAL, WAS THE ORGANISM STAINED OR IDENTIFIED? IF IDENTIFIED, WHAT WAS THE SPECIES AND CONFIDENCE LEVEL OF THE IDENTIFIED SPECIES? SEE ABOVE. GRAM STAIN RESULT: GRAM-POSITIVE ROD. DNA SEQUENCING WAS ALSO UNSUCCESSFUL. WERE ANY PATIENT RESULTS AFFECTED DUE TO THE CONTAMINATION? NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 100 TUBES OF BD BBL¿ TRYPTICASE¿ SOY BROTH WERE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING CONTAMINATION WITH THEIR 297354 TUBES FROM LOT 2062203. THEY FOUND THE CONTAMINATION DURING TESTING OF BIOLOGICAL INDICATORS. HOW MANY INDIVIDUAL TUBES DID YOU FIND TO BE CONTAMINATED?1 FULL RACK (100CT) WHEN WAS THE CONTAMINATION OBSERVED? BEFORE OR AFTER INOCULATION/INCUBATION? TURBIDITY AND THE PRESENCE OF WHAT APPEARED TO BE BACTERIAL CELLS WAS OBSERVED ON TUBES THAT HAD BEEN USED/INCUBATED FOR AN ASSAY. IT WAS LATER DISCOVERED ON THE ENTIRETY OF THE 100CT RACK THAT THEY HAD BEEN TAKEN FROM. WAS THE CONTAMINATION BIOLOGICAL IN NATURE OR FOREIGN MATTER? IT APPEARED BIOLOGICAL (BACILLI) MICROSCOPICALLY. ATTEMPTS TO ISOLATE AND CULTURE WERE UNSUCCESSFUL. IF BIOLOGICAL, WAS THE ORGANISM STAINED OR IDENTIFIED? IF IDENTIFIED, WHAT WAS THE SPECIES AND CONFIDENCE LEVEL OF THE IDENTIFIED SPECIES? SEE ABOVE. GRAM STAIN RESULT: GRAM-POSITIVE ROD. DNA SEQUENCING WAS ALSO UNSUCCESSFUL. WERE ANY PATIENT RESULTS AFFECTED DUE TO THE CONTAMINATION? NO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597051 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