BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) PLATE 100PK

    MDR report key: 20401468 · Received October 8, 2024

    Report

    Report Number
    1119779-2024-00742
    Event Type
    Malfunction
    Date Received
    October 8, 2024
    Date of Event
    September 10, 2024
    Report Date
    January 8, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    10382902212833
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION. D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 18-SEP-2024. INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS REGARDING THE COMPLAINT RELATED TO CATALOG NUMBER 221283, PLATE TRYPTICASE SOY AGAR 100 EA, BATCH NUMBER 4191258 AND BD COMPLAINT NUMBER (B)(6) FOR MISSING SLEEVE LABELS. 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 4191258 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE SLEEVE ATTRIBUTE TESTING. SAMPLE PLATES ARE INCUBATED AT 25 DEGREES C AND AT 35 DEGREES C FOR APPROXIMATELY 72 HOURS. THEY ARE TESTED FOR SLEEVE ATTRIBUTES PRIOR TO RELEASE TO ENSURE THAT THEY CONFORM TO PRODUCT SPECIFICATION. ALL SLEEVE ATTRIBUTE TESTING PERFORMED ON THIS BATCH WAS SATISFACTORY PER BD INTERNAL PROCEDURES. THE COMPLAINT HISTORY WAS REVIEWED, AND THE ONLY COMPLAINTS TAKEN ON BATCH 4191258 WERE FROM MERCK (COMPLAINT NUMBER (B)(6) FOR MISSING SLEEVE LABELS AND COMPLAINT NUMBER (B)(6) FOR CONTAMINATION). RETENTION SAMPLES FROM BATCH 4191258 WERE NOT AVAILABLE FOR INSPECTION. FORTY PLATES FROM BATCH 4191258 WERE RETURNED AS FOUR UNOPENED SLEEVES SHIPPED IN A BOX WITH AIR BUBBLES. TWO OF THE SLEEVES RECEIVED DID NOT HAVE A SLEEVE LABEL. PLATES WERE INSPECTED AND 40/40 PLATES HAD A COMPLETE PLATE PRINT (TIME STAMP 2153). TWO PHOTOS ALSO WERE RECEIVED FOR INVESTIGATION. ONE PHOTO SHOWS TWO SLEEVES WITHOUT A SLEEVE LABEL. THE OTHER SHOWS THE PRINT ON THE TOP OF AN UNOPENED SLEEVE FROM BATCH 4191528 (TIME STAMP 2149). IT IS NOTED THAT THIS PRODUCT IS PACKAGED INTO SLEEVES AND LABELED VIA AN AUTOMATED PROCESS. IF A FAILURE IN THE SLEEVE LABELING PROCESS OCCURS, EACH PLATE OF THIS PRODUCT IS LABELED SO THE MEDIA TYPE, BATCH NUMBER AND EXPIRATION DATE ARE READILY AVAILABLE. THIS COMPLAINT CAN BE CONFIRMED FOR MISSING SLEEVE LABELS. NO COMPLAINT TREND HAS BEEN IDENTIFIED FOR LABELING; NO ACTIONS ARE INDICATED AT THIS TIME PER BD PROCEDURES. BD WILL CONTINUE TO TREND COMPLAINTS FOR LABELING. IF THERE ARE FURTHER QUESTIONS, PLEASE CONTACT TECHNICAL SERVICES.

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER ADDRESS: (B)(6). 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 · 0

    IT WAS REPORTED PRIOR TO USING BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) PLATE 100PK THAT FOUR (4) SLEEVES WERE MISSING THE PRODUCT LABEL. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) PLATE 100PK THAT FOUR (4) SLEEVES WERE MISSING THE PRODUCT LABEL. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744978 BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) PLATE 100PK CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON DICKINSON & CO. (SPARKS) 4191258 10382902212833

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown