BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12178032 · Received July 15, 2021

    Report

    Report Number
    1119779-2021-01174
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    June 14, 2021
    Report Date
    January 20, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    10382902212918
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: DURING MANUFACTURING OF MATERIAL 221291, 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 1091016 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE PHYSICAL ATTRIBUTE TESTING. A SAMPLE OF PLATES ARE INCUBATED AT 25 DEGREES C AND AT 35 DEGREES C FOR APPROXIMATELY 72 HOURS. THEY ARE TESTED FOR PHYSICAL ATTRIBUTES PRIOR TO RELEASE TO ENSURE THAT THEY CONFORM TO PRODUCT SPECIFICATIONS. ALL PHYSICAL ATTRIBUTE TESTING PERFORMED ON THIS BATCH WAS SATISFACTORY PER BD INTERNAL PROCEDURES. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 1091016. RETENTION SAMPLES FROM BATCH 1091016 WERE NOT AVAILABLE FOR INSPECTION. ONE UNOPENED SLEEVE (10 PLATES) FROM BATCH 1091016 WAS RETURNED FOR INVESTIGATION SHIPPED IN A BOX WITH PAPER PADDING. PLATES WERE INSPECTED AND 10/10 PLATES HAD SURFACE BACTERIAL GROWTH ON BOTH MEDIA (TIME STAMP 2351). ONE AFFECTED PLATE WAS SUBMITTED TO THE ID LAB AND PSEUDOMONAS FLUORESCENS WAS IDENTIFIED. SEVEN PHOTOS ALSO WERE RECEIVED FOR INVESTIGATION. ONE PHOTO SHOWS THE SURFACE OF FIVE PLATES FROM BATCH 1091016 (TIME STAMP 2309) WITH SURFACE BACTERIAL GROWTH IN EACH MEDIA OF EACH PLATE. ONE PHOTO SHOWS THE SIDE OF A SLEEVE WITH MICROBIAL GROWTH VISIBLE IN EACH PLATE. FIVE PHOTOS EACH SHOW THE SURFACE OF AN OPENED BI-PLATE WITH SURFACE BACTERIAL COLONIES ON EACH MEDIA. THIS COMPLAINT CAN BE CONFIRMED. A TREND WAS IDENTIFIED FOR CONTAMINATION AND INVESTIGATION FOUND OPPORTUNITIES FOR BIOBURDEN REDUCTION IN THE MANUFACTURING PROCESS. A CAPA (CORRECTIVE AND PREVENTATIVE ACTIONS) 3076308 HAS BEEN INITIATED AND INVOLVES IMPLEMENTING ADDITIONAL CLEANING EVENTS AND EVALUATION OF MANUFACTURING PROCEDURES FOCUSED ON IN-PROCESS BIOBURDEN REDUCTION. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 18 BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) // MACCONKEY II AGARS MOLD CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT MOLD CONTAMINATION NOTED UPON OPENING."

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING 18 BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) // MACCONKEY II AGARS MOLD CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT MOLD CONTAMINATION NOTED UPON OPENING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074298 BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) // MACCONKEY II AGAR CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 221291 1091016 10382902212918

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown