BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TRYPTICASE¿ SOY BROTH

    MDR report key: 17921493 · Received October 12, 2023

    Report

    Report Number
    1119779-2023-01097
    Event Type
    Malfunction
    Date Received
    October 12, 2023
    Date of Event
    September 12, 2023
    Report Date
    December 6, 2023
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    30382902210932
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: MATERIAL 221093 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 3129898 WAS SATISFACTORY PER INTERNAL PROCEDURES. FORMULATION, FILLING, TORQUING, AND AUTOCLAVING PROCESSES WERE WITHIN SPECIFICATIONS. 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 ONE OTHER COMPLAINT HAS BEEN TAKEN ON THIS BATCH FOR CONTAMINATION. RETENTION SAMPLES FROM BATCH 3129898 (10 TUBES) WERE AVAILABLE FOR INSPECTION. NO MICROBIAL GROWTH OR TURBIDITY WERE OBSERVED IN 10/10 RETENTION TUBES. RETENTION TUBES WERE INCUBATED FOR INVESTIGATION AT 20 TO 25 DEGREES C (1 TUBE) AND 33 TO 37 DEGREES C (1 TUBE). AT SEVEN DAYS INCUBATION, NO MICROBIAL GROWTH WAS OBSERVED IN 2/2 TUBES. FOUR PHOTOS WERE RECEIVED FOR INVESTIGATION. TWO PHOTOS EACH SHOW TWO TUBES OF TSB HELD UP WITH WHAT APPEARS TO A FAINT SWIRL OF HAZE TOWARD THE BOTTOM OF THE TUBE. ONE PHOTO SHOWS THE SIDE OF FOUR CARTONS FROM BATCH 3129898 WITH THE CARTON LABELS FEATURED (CARTON NUMBERS 446 AND 442 VISIBLE) FOR BATCH VERIFICATION. THE LAST PHOTO FEATURES A CARTON LABEL FROM ENRICHED THIOGLYCOLLATE BROTH, MATERIAL 221788, BATCH 3187508 (CARTON NUMBER 0212) WHICH IS THE SUBJECT OF ANOTHER COMPLAINT FROM COMMUNITY BLOOD CENTER (COMPLAINT NUMBER 9044971). NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. THE HAZINESS SHOWN IN THE PHOTO COULD BE DUE TO CONTAMINATION. HOWEVER, THE HAZINESS IN THE PHOTO CANNOT BE IDENTIFIED FOR FURTHER INVESTIGATION. THE CLARITY SPECIFICATION FOR THIS PRODUCT IS CLEAR TO TRACE HAZY. MEDIA THAT IS OUTSIDE OF THE APPEARANCE SPECIFICATION SHOULD NOT BE USED. IT SHOULD BE NOTED THAT NON-VIABLE ORGANISMS CAN CONTRIBUTE TO A HAZY APPEARANCE OF THE MEDIA. IF NON-VIABLES ARE PRESENT AND CAUSING THE MEDIA TO APPEAR OUT OF SPECIFICATION FOR CLARITY, THE MEDIA SHOULD NOT BE USED. 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. PRODUCT SHOULD NOT BE USED IF MEDIUM SHOWS EVIDENCE OF CONTAMINATION, DISCOLORATION, DRYING OR OTHER SIGNS OF DETERIORATION. THIS COMPLAINT CAN BE CONFIRMED BY THE PHOTO FOR TURBIDITY THAT MAY BE CONTAMINATION. BD WILL CONTINUE TO TREND COMPLAINTS FOR DEFECTS.

    Additional Manufacturer Narrative · 0

    H.3. 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 THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH, THERE WAS CONTAMINATION OF AN UNSPECIFIED NUMBER OF TUBES. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS REPORTING CONTAMINATED TUBES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH, THERE WAS CONTAMINATION OF AN UNSPECIFIED NUMBER OF TUBES. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS REPORTING CONTAMINATED TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1311465 BD BBL¿ TRYPTICASE¿ SOY BROTH CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON DICKINSON & CO. (SPARKS) 3129898 30382902210932

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown