BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15171830 · Received August 4, 2022

    Report

    Report Number
    1119779-2022-01072
    Event Type
    Malfunction
    Date Received
    August 4, 2022
    Date of Event
    July 14, 2022
    Report Date
    March 27, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: 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 REVIEW FOR BATCH 2132144 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 AND BIOBURDEN TESTING. A SAMPLE OF PLATES ARE INCUBATED AT 25 DEGREES C AND AT 35 DEGREES C FOR APPROXIMATELY 72 HOURS. ALL PHYSICAL ATTRIBUTE AND BIOBURDEN TESTING PERFORMED ON THIS BATCH WAS SATISFACTORY PER BD INTERNAL PROCEDURES. AFFECTED PRODUCT DOES NOT HAVE ANY STERILITY CLAIMS; THE PRODUCT IS. TESTED FOR BIOBURDEN PRIOR TO RELEASE TO ENSURE THAT IT CONFORMS TO PRODUCT SPECIFICATIONS. HOWEVER, THIS DOES NOT ENSURE THAT THE END-USER WILL NOT RECEIVE A CONTAMINATED PLATE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 2132144. RETENTION SAMPLES WERE NOT AVAILABLE FOR INSPECTION. TWENTY PLATES FROM BATCH 2132144 WERE RETURNED AS TWO UNOPENED SLEEVES SHIPPED IN AN INSULATED BOX WITH ICE PACKS. PRIOR TO INSPECTION, SLEEVES WERE INCUBATED AT 20 TO 25 DEGREES C (1 SLEEVE) AND 33 TO 37 DEGREES C (1 SLEEVE). AT THREE DAYS INCUBATION, PLATES WERE INSPECTED AND 0/20 PLATES HAD MICROBIAL GROWTH (TIME STAMPS 0436). IT IS NOTED THAT SOME PLATES DID HAVE DRIED SURFACE MOISTURE. FOUR PHOTOS WERE RECEIVED FOR INVESTIGATION. TWO PHOTOS EACH SHOW THE AGAR SURFACE OF AN OPENED PLATE. THE OTHER TWO PHOTOS EACH SHOW THE AGAR SURFACE OF AN OPENED PLATE WITH WHAT APPEARS TO BE DRIED MOISTURE ON THE AGAR SURFACE. THE MAIN COMPONENT OF PREPARED PLATED MEDIA IS PURIFIED WATER. THE PURIFIED WATER IS HELD IN AN AGAR MATRIX IN THE MEDIA. RELEASE OF THE PURIFIED WATER AS THE MATRIX CONTRACTS DURING TEMPERATURE CYCLING AND PROGRESSION THROUGH SHELF LIFE IS REFERRED TO AS EXUDATION. EXUDATE MAY CONTAIN MEDIA COMPONENTS THAT WILL PRESENT AS TEXTURE OR DISCOLORATION ON THE AGAR SURFACE AS THE MOISTURE DRIES. DRIED SURFACE MOISTURE MAY ALSO LOOK SIMILAR TO POSSIBLE CONTAMINATION AS WELL. DRIED SURFACE MOISTURE IS NOT CONSIDERED A DEFECT. THIS COMPLAINT CANNOT BE CONFIRMED FOR CONTAMINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) PLATES WERE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT. APPROXIMATELY, 50-75% PER SLEEVE WERE AFFECTED. NO EXACT QUANTITY AFFECTED AVAILABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE IS CONTAMINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) PLATES WERE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT. APPROXIMATELY, 50-75% PER SLEEVE WERE AFFECTED. NO EXACT QUANTITY AFFECTED AVAILABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE IS CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1931265 BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 2132144

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown