BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II)

    MDR report key: 15849103 · Received November 22, 2022

    Report

    Report Number
    1024879-2022-00683
    Event Type
    Malfunction
    Date Received
    November 22, 2022
    Date of Event
    November 8, 2022
    Report Date
    February 10, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 THIS MEMO IS TO SUMMARIZE FINDINGS REGARDING THE COMPLAINT RELATED TO CATALOG NUMBER 221261, PLATE TRYPTICASE SOY AGAR 5% SB 100 EA, BATCH NUMBER 2291809 AND BD COMPLAINT NUMBER (B)(4) FOR MISSING SLEEVE LABELS. DURING MANUFACTURING OF MATERIAL 221261, 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 2291809 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE PHYSICAL AND SLEEVE ATTRIBUTE TESTING. SAMPLE PLATES ARE INCUBATED AT 25 DEGREES C AND AT 35 DEGREES C FOR APPROXIMATELY 72 HOURS. THEY ARE TESTED FOR PHYSICAL AND SLEEVE ATTRIBUTES PRIOR TO RELEASE TO ENSURE THAT THEY CONFORM TO TYPICAL LEVELS. ALL PHYSICAL AND SLEEVE ATTRIBUTE TESTING PERFORMED ON THIS BATCH WAS SATISFACTORY PER OUR INTERNAL PROCEDURES. THE COMPLAINT HISTORY WAS REVIEWED, AND THE COMPLAINTS ON THIS BATCH WERE FROM MODERNA FOR MISSING SLEEVE LABELS (COMPLAINT NUMBER (B)(4)) AND BROKEN PLATES (COMPLAINT NUMBER (B)(4)). RETENTION SAMPLES FROM BATCH 2291809 WERE NOT AVAILABLE FOR INSPECTION. THIRTY PLATES FROM BATCH 2291809 WERE RETURNED AS THREE UNOPENED SLEEVES SHIPPED IN A BOX WITH BUBBLE WRAP. ONE OF THE THREE SLEEVES RETURNED DID NOT HAVE A SLEEVE LABEL. THREE PHOTOS ALSO WERE RECEIVED FOR INVESTIGATION. THE THREE PHOTOS EACH SHOW A SLEEVE OF MEDIUM RED AGAR PLATES WITH NO SLEEVE LABEL VISIBLE. 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 AND EXPIRATION DATE ARE READILY AVAILABLE. THIS COMPLAINT CAN BE CONFIRMED FOR A MISSING SLEEVE LABEL. NO COMPLAINT TRENDS FOR LABELING DEFECTS HAVE BEEN IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. HOWEVER, BD STRIVES TO IMPROVE. MANUFACTURING OPERATIONS HAS BEEN MADE AWARE OF THE MISSING SLEEVE COMPLAINTS FROM MODERNA TO HELP IDENTIFY POTENTIAL OPPORTUNITIES TO IMPROVE. BD DOES NOT SPECULATE ON POSSIBLE ROOT CAUSE AND PER BD PROCEDURES, A ROOT CAUSE ANALYSIS IS NOT INDICATED AS BD HAS NOT IDENTIFIED A COMPLAINT TREND FOR MISSING SLEEVE LABELS. BD WILL CONTINUE TO TREND COMPLAINTS FOR LABELING DEFECTS. IF THERE ARE FURTHER QUESTIONS, PLEASE CONTACT TECHNICAL SERVICES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) DID NOT HAVE ANY LABELS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT THE PRODUCT 221261 DID NOT HAVE ANY LABEL ON THEM. LOT#2291809. SCAR QE-023355 DOCUMENT ATTACHED. HAZARD, INJURY OR ERRONEOUS RESULTS? NO. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) DID NOT HAVE ANY LABELS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT THE PRODUCT 221261 DID NOT HAVE ANY LABEL ON THEM. LOT#2291809. SCAR (B)(4) DOCUMENT ATTACHED. HAZARD, INJURY OR ERRONEOUS RESULTS? NO. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292534 BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 2291809

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown