BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL TRYPTICASE SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR)

    MDR report key: 11622072 · Received April 6, 2021

    Report

    Report Number
    1119779-2021-00616
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Date of Event
    March 16, 2021
    Report Date
    September 18, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    10382902212833
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-03-30 INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS REGARDING THE COMPLAINT RELATED TO CATALOG NUMBER 221283, PLATE TRYPTICASE SOY AGAR 100 EA, FOR BATCH NUMBER 1021745 AND COMPLAINT # (B)(4) FOR PERFORMANCE. DURING MANUFACTURING OF MATERIAL 221283, MEDIA IS FORMULATED AND SENT THROUGH A HIGH TEMPERATURE SHORT TIME STERILIZER TO REMOVE BIOBURDEN. THE PETRI DISHES ARE SUBJECTED TO UV RADIATION TO DECREASE BIOBURDEN. THE PETRI DISHES ARE FILLED IN A POSITIVE PRESSURE HEPA FILTERED ENVIRONMENT. THE FILLED PLATES ARE COOLED AND IMMEDIATELY WRAPPED INTO SLEEVES TO DECREASE THE INTRODUCTION OF MICROBES. SLEEVES ARE THEN PACKAGED INTO CARTONS AND THEN TRANSFERRED TO A REFRIGERATED TRUCK (2 TO 8 DEGREES C) FOR SHIPMENT TO THE DISTRIBUTOR. BD DISTRIBUTORS ARE PROVIDED WITH THE STORAGE GUIDELINES FOR THE SHIPPING AND HANDLING OF BD MEDIA OF 2 TO 8 DEGREES C IN A DARK PLACE. THE BATCH HISTORY RECORD FOR BATCH 1021745 WAS SATISFACTORY AT TIME OF RELEASE AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. ALL BATCHES ARE TESTED PRIOR TO RELEASE AND RESULTS REPORTED ON THE CERTIFICATE OF ANALYSIS (COA) WHICH CAN BE OBTAINED AT WWW.BD.COM/REGDOCS. TRYPTICASE SOY AGAR IS STABILITY TESTED BIENNIALLY FOR BIOLOGICAL PERFORMANCE TO ENSURE SATISFACTORY PERFORMANCE THROUGHOUT SHELF LIFE WITH THE ORGANISMS THAT ARE REPORTED ON THE CERTIFICATE OF ANALYSIS. ALL PERFORMANCE TESTING ON THIS BATCH WAS SATISFACTORY AT THE TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 1021745. RETENTION SAMPLES FROM BATCH 1021745 WERE NOT AVAILABLE FOR INSPECTION. RETURNS WERE RECEIVED FOR INVESTIGATION. ONE HUNDRED PLATES FROM BATCH 1021745 WERE RETURNED AS 10 UNOPENED SLEEVES SHIPPED IN A BOX WITH AIR BUBBLES (TIME STAMPS 1141, 1147, 1148, 1207 AND 1208). RETURN PLATES WERE TESTED PER THE STANDARD PERFORMANCE PROTOCOL FOR MATERIAL 221283 FOR PSEUDOMONAS AERUGINOSA ATCC 9027 AS DESCRIBED IN THE COA. RETURNED PLATES HAD HEAVY GROWTH OF ATCC 9027 AT TWO DAYS INCUBATION. TSA CONTROL ALSO HAD HEAVY GROWTH. RECOVERY OF ATCC 9027 ON RETURNED PLATES AS COMPARED TO THE TSA CONTROL AVERAGED 94%. RECOVERY WAS WITHIN THE SPECIFICATION OF 50 TO 200%. NO PHOTOS WERE RECEIVED FOR INVESTIGATION. RETENTION SAMPLE TESTING WAS SATISFACTORY FOR ATCC 9027. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) 800 PLATES FAILED GROWTH PROMOTION. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT FAILED GROWTH PROMOTION OF PRODUCT 1. QC ORGANISM(S) THAT FAILED TESTING: PSEUDOMONAS AERUGINOSA ATCC 9027 ORGANISM MAINTENANCE: ATCC MICROORGANISM. GROWN ON TSA SLANTS. HARVESTED AND DILUTED AS NECESSARY. 2. INCUBATION WHAT TYPE OF INCUBATOR IS USED (CO2, ETC)?: STANDARD TEMPERATURE- CONTROLLED INCUBATOR. TEMPERATURE OF INCUBATION: 30-35C TIME INCUBATED: 42 HOURS 3. RESULTS WILL RESULTS BE REPORTED AS CFU RECOVERED OR GROWTH/NO GROWTH?: CFU RECOVERED AS PERCENT OF CONTROL COUNT. 4. OTHER HOW LONG HAS THIS MEDIA BEEN IN USE AT THIS FACILITY?: FIRST TIME BD TSA MEDIA USED. THIS BATCH WAS NOT USED FOR ANY RELEASE TESTING. IS THIS THE FIRST TESTING FAILURE?: YES FOR TSA FOR P. AERUGINOSA MULTIPLE OR SINGLE TECHNOLOGIST PERFORMING THIS TEST?: INITIAL TEST: ONE MICROBIOLOGIST, RETEST: TWO DIFFERENT MICROBIOLOGISTS. DO YOU HAVE LOT NUMBERS THAT WORKED IN THE PAST? NO

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) 800 PLATES FAILED GROWTH PROMOTION. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT FAILED GROWTH PROMOTION OF PRODUCT QC ORGANISM(S) THAT FAILED TESTING: PSEUDOMONAS AERUGINOSA ATCC 9027. ORGANISM MAINTENANCE: ATCC MICROORGANISM. GROWN ON TSA SLANTS. HARVESTED AND DILUTED AS NECESSARY. INCUBATION: WHAT TYPE OF INCUBATOR IS USED (CO2, ETC)?: STANDARD TEMPERATURE- CONTROLLED INCUBATOR. TEMPERATURE OF INCUBATION: 30-35C. TIME INCUBATED: 42 HOURS. RESULTS: WILL RESULTS BE REPORTED AS CFU RECOVERED OR GROWTH/NO GROWTH?: CFU RECOVERED AS PERCENT OF CONTROL COUNT. OTHER: HOW LONG HAS THIS MEDIA BEEN IN USE AT THIS FACILITY?: FIRST TIME BD TSA MEDIA USED. THIS BATCH WAS NOT USED FOR ANY RELEASE TESTING. IS THIS THE FIRST TESTING FAILURE?: YES FOR TSA FOR P. AERUGINOSA. MULTIPLE OR SINGLE TECHNOLOGIST PERFORMING THIS TEST?: INITIAL TEST: ONE MICROBIOLOGIST, RETEST: TWO DIFFERENT MICROBIOLOGISTS. DO YOU HAVE LOT NUMBERS THAT WORKED IN THE PAST? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521940 BD BBL TRYPTICASE SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 221283 1021745 10382902212833

    Patients

    Seq Age Sex Outcome Treatment
    1