BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TRYPTICASE¿ SOY BROTH

    MDR report key: 14628477 · Received June 7, 2022

    Report

    Report Number
    1119779-2022-00829
    Event Type
    Malfunction
    Date Received
    June 7, 2022
    Date of Event
    May 13, 2022
    Report Date
    October 28, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    30382902218150
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: MATERIAL 221815 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. UNKNOWN BATCH 008275 BATCH NUMBER 008275 WAS PROVIDED FOR INVESTIGATION. THE BATCH HISTORY RECORD REVIEW FOR BATCH 008275 YIELDED NO RESULT. THERE IS NO PRODUCTION RECORD OF MATERIAL 221815 BATCH NUMBER 008275. NO RETURN SAMPLES WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. NO PHOTOS WERE RECEIVED TO ASSIST WITH THIS INVESTIGATION. RETENTION SAMPLES CANNOT BE EVALUATED WITHOUT A SPECIFIC BATCH NUMBER. TRENDING WAS DONE ON THE APPROPRIATE DATABASES FOR TRYPTICASE SOY BROTH 2ML (MATERIAL 221815) AND NO QUALITY NOTIFICATION TRENDS HAVE BEEN IDENTIFIED FOR THIS MATERIAL FOR PERFORMANCES OR APPEARANCE IN THE LAST 12 MONTHS. THE COMPLAINT HISTORY WAS REVIEWED FOR MATERIAL 221815 AND THERE ARE NO TRENDS FOR PERFORMANCES OR APPEARANCE IN THE LAST 12 MONTHS. THIS COMPLAINT CANNOT BE CONFIRMED BASED ON MATERIAL TRENDING. NO ACTIONS ARE INDICATED AT THIS TIME AND BD WILL CONTINUE TO TREND COMPLAINTS FOR THIS ISSUE. UNKNOWN BATCH 206466 BATCH NUMBER 206466 WAS PROVIDED FOR INVESTIGATION. THE BATCH HISTORY RECORD REVIEW FOR BATCH 206466 YIELDED NO RESULT. THERE IS NO PRODUCTION RECORD OF MATERIAL 206466 BATCH NUMBER 206466. NO RETURN SAMPLES WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. NO PHOTOS WERE RECEIVED FOR TO ASSIST WITH THE INVESTIGATION. RETENTION SAMPLES CANNOT BE EVALUATED WITHOUT A SPECIFIC BATCH NUMBER. TRENDING WAS DONE ON THE APPROPRIATE DATABASES FOR TRYPTICASE SOY BROTH 2ML (MATERIAL 221815) AND NO QUALITY NOTIFICATION TRENDS HAVE BEEN IDENTIFIED FOR THIS MATERIAL FOR PERFORMANCES OR APPEARANCE IN THE LAST 12 MONTHS. THE COMPLAINT HISTORY WAS REVIEWED FOR MATERIAL 221815 AND THERE ARE NO TRENDS FOR PERFORMANCES OR APPEARANCE IN THE LAST 12 MONTHS. THIS COMPLAINT CANNOT BE CONFIRMED BASED ON MATERIAL TRENDING. NO ACTIONS ARE INDICATED AT THIS TIME AND BD WILL CONTINUE TO TREND COMPLAINTS FOR THIS ISSUE. IT IS TO BE NOTED THAT BD DOES SELL DCM PRODUCTS AND AGAR PRODUCTS, HOWEVER THIS LIQUID MEDIA PRODUCT IS TO BE USED AS IS PER PRODUCT CLAIMS. THE ADDITION OF ANY MATERIAL TO THIS MEDIA IS NOT WITHIN PRODUCT CLAIMS PER THE PACKAGE INSERT. NOTES: RISK MANAGEMENT REVIEW INDICATES THE POTENTIAL RISKS OF THE DEFECTS REPORTED WERE ASSESSED AS SEVERITY [S2], PER [BALTRMTERMINALGPAPH], REV [02], ID [2.21] FOR [ATYPICAL GROWTH] AND SEVERITY [S1], PER [BALTRMTERMINALGPAPH], REV [02], ID [4.0] FOR [COLOR VARIATION] AND SEVERITY [S3], PER [BALTRMTERMINALGPAPH], REV [02], ID [2.31] FOR [PH].

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD BBL¿ TRYPTICASE¿ SOY BROTH HAS BEEN FOUND EXPERIENCING PERFORMANCE ISSUES. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THEY ARE GETTING INCONSISTENT GROWTH, COLOR AND PH WHEN ADDING AGAR TO THEIR 221815 PREPARED TUBES TO MAKE TSA PLATES.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD BBL¿ TRYPTICASE¿ SOY BROTH HAS BEEN FOUND EXPERIENCING PERFORMANCE ISSUES. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THEY ARE GETTING INCONSISTENT GROWTH, COLOR AND PH WHEN ADDING AGAR TO THEIR 221815 PREPARED TUBES TO MAKE TSA PLATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2197443 BD BBL¿ TRYPTICASE¿ SOY BROTH CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 221815 UNKNOWN 30382902218150

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown