BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TRYPTICASE¿ SOY BROTH

    MDR report key: 14176718 · Received April 21, 2022

    Report

    Report Number
    1119779-2022-00583
    Event Type
    Malfunction
    Date Received
    April 21, 2022
    Date of Event
    March 23, 2022
    Report Date
    November 16, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    30382902217160
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: MATERIAL 221716 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 2026705 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING, TORQUEING, AND AUTOCLAVING PROCESSES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING WAS SATISFACTORY AT TIME OF RELEASE. DIRECT STAINING TECHNIQUES ARE NOT PART OF QC RELEASE TESTING FOR THIS PRODUCT. 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 FOR CONTAMINATION OR LOOSE CAPS. RETENTION SAMPLES FROM BATCH 2026705 (10 TUBES) WERE AVAILABLE FOR INSPECTION. NO MEDIA DEFECTS SUCH AS TURBID/CONTAMINATION WERE OBSERVED IN 10/10 RETENTION SAMPLES. ALL RETENTIONS TUBES HAD THE EXPECTED APPEARANCE FOR MATERIAL 221716 OF LIGHT TO MEDIUM LIGHT YELLOW, TRACE HAZY TO CLEAR AS SPECIFIED IN THE CERTIFICATE OF ANALYSIS. THERE WAS NO EVIDENCE OF LOOSE CAPS IN 10/10 RETENTION SAMPLES. FOR FURTHER INVESTIGATION, TWO RETENTION SAMPLE TUBES WERE TESTED FOR CONTAMINATION. ONE RETENTION TUBE WAS INCUBATED IN THE 20-25 DEGREE C INCUBATOR AND ONE RETENTION TUBE WAS PLACED IN THE 33-37 DEGREE C INCUBATOR. AT 7 DAYS INCUBATION, THERE WERE NO SIGNS OF GROWTH OR TURBIDITY FROM 2/2 INCUBATED RETENTION TUBES. TWO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION: THE FIRST PHOTO SHOWS AN OPEN 100 PACK CARTON WITH EIGHT TUBES IN THE TUBE RACK. THERE ALSO IS A PARTIAL OPENED CARTON IN THE CORNER OF THE PHOTO. THE CAPS OF SEVEN TUBES CAN BE OBSERVED. THE MEDIA CANNOT BE OBSERVED IN THE PHOTO. A LOOSE CAP DEFECT CANNOT BE OBSERVED FROM THE PHOTO. THE LAST PHOTO SHOWS A CLOSED CARTON FROM BATCH 2026705. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. BASED ON THE EVIDENCE PROVIDED BY THE PHOTOS THIS COMPLAINT CANNOT BE CONFIRMED FOR CONTAMINATION OR LOOSE CAPS. BD WILL CONTINUE TO TREND COMPLAINTS FOR LOOSE CAPS AND CONTAMINATION. NO ADDITIONAL ACTIONS ARE INDICATED AT THIS TIME. NOTES: RISK MANAGEMENT REVIEW INDICATES THE POTENTIAL RISKS OF THE DEFECTS REPORTED WERE ASSESSED AS SEVERITY [01], PER BALTRMTERMINALGPAPH], REV [02], ID [18.0] FOR [CONTAMINATION] AND SEVERITY [S1], PER [BALTRMTERMINALGPAPH], REV [02], ID [4.6] FOR [CAP DEFECTS].

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD BBL¿ TRYPTICASE¿ SOY BROTH HAS BEEN FOUND CONTAINING BIOLOGICAL CONTAMINATION. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS 1 TUBE ARRIVES WITH CONTAMINATION IN 221716 LOT 2026705. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: OPENED A COMPLAINT. CUSTOMER RECEIVED 1 TUBE THAT WAS CONTAMINATED UPON ARRIVAL. TUBE WAS DISCARDED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD BBL¿ TRYPTICASE¿ SOY BROTH HAS BEEN FOUND CONTAINING BIOLOGICAL CONTAMINATION. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS 1 TUBE ARRIVES WITH CONTAMINATION IN 221716 LOT 2026705. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: OPENED A COMPLAINT. CUSTOMER RECEIVED 1 TUBE THAT WAS CONTAMINATED UPON ARRIVAL. TUBE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934526 BD BBL¿ TRYPTICASE¿ SOY BROTH CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 221716 2026705 30382902217160

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown