BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD

    MDR report key: 11724424 · Received April 26, 2021

    Report

    Report Number
    1119779-2021-00714
    Event Type
    Malfunction
    Date Received
    April 26, 2021
    Date of Event
    March 31, 2021
    Report Date
    October 4, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: 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 FOR BATCH 1050297 WAS SATISFACTORY AT TIME OF RELEASE AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE BIOBURDEN TESTING. A SAMPLE OF PLATES ARE INCUBATED AT 25 DEGREES C AND AT 35 DEGREES C FOR APPROXIMATELY 72 HOURS. ALL 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 1050297 FOR CONTAMINATION. RETENTION SAMPLES FROM BATCH 1050297 WERE NOT AVAILABLE FOR INSPECTION. TWO PHOTOS WERE RECEIVED FOR INVESTIGATION. BOTH PHOTOS ARE SIMILAR; EACH SHOWS THE AGAR SURFACE OF A PLATE WITH GROWTH OF A VARIETY OF COLONY MORPHOLOGIES. IT IS DIFFICULT TO DISCERN IF PLATES HAVE BEEN INOCULATED OR NOT FROM THE PHOTOS. NO PLATE PRINTS OR PRODUCT LABELS ARE VISIBLE IN THE PHOTOS FOR BATCH VERIFICATION. BATCH VERIFICATION IS REQUIRED TO CONFIRM COMPLAINTS BY PHOTOS. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER INOCULATION AND INCUBATION, CONTAMINATION OF BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD WAS DISCOVERED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTING BLOOD AGAR PLATES 221261 PLATES WITH CONTAMINATION. CUSTOMER STATES THERE WAS NOT ANY CHANGE TO PATIENT TREATMENT DUE TO THE CONTAMINATION BEING REPORTED OUT. ADDITIONALLY, THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: PLACED FOLLOW UP CALL TO CUSTOMER TO GET MORE INFORMATION ABOUT ISSUE. THEY STATE THEY HAD SEVERAL PLATES SHOWING BACILLUS SP. AND A GRAM NEGATIVE ROD. THIS CONTAMINATION WAS SEEN AFTER THE PLATES WERE INOCULATED AND INCUBATED. THE ORGANISMS WERE NOT PRESENT ON CHOCOLATE AGAR PLATES OR ANAEROBIC PLATES. THEY STATE THE PLATES ARE RECEIVED IN THE LOADING DOCK AREA AND IMMEDIATELY BROUGHT TO THE LAB AND REFRIGERATED. THEY ARE LEFT REFRIGERATED UNTIL READY TO USE. CUSTOMER DID NOT HAVE A TOTAL PLATE COUNT OF HOW MANY INDIVIDUAL PLATES WERE AFFECTED BUT THEY STATE THEY WILL LOOK INTO THAT. THEY ARE ALSO GOING TO TRY TO GET PICTURES OF THE PLATES WITH THE CONTAMINATION ON THEM. CUSTOMER DOES NOT HAVE ANY 221261 PLATES OF THE LOT NUMBER 1050297 LEFT TO SEND IN FOR QUALITY INVESTIGATION. CAN YOU PLEASE PROVIDE THE TIME STAMP ON THE BOTTOM OF THE PLATES? UNABLE TO OBTAIN. ARE THESE SHIPPED TO YOU FROM A DISTRIBUTOR OR DIRECTLY FROM BD? DISTRIBUTOR . IF FROM A DISTRIBUTOR WHICH ONE? CARDINAL. WERE THE PLATES RECEIVED REFRIGERATED ON YOUR LOADING DOCK? YES. HOW ARE THE PLATES STORED ONCE RECEIVED AND AT WHAT TEMPERATURE? REFRIGERATED. ARE THE SLEEVES SEALED DURING STORAGE? YES. HOW MANY BOXES OF LOT 10502967 DID YOU RECEIVE?10 CASES OF 100. OUT OF THE BOXES RECEIVED OF LOT NUMBER 10502967, HOW MANY INDIVIDUAL PLATES FROM LOT DID YOU NOTICE CONTAMINATION ON? ABOUT 10-20. AS YOU STATED ON THE PHONE, THE CONTAMINATION WAS NOT NOTICED PRIOR TO INOCULATION AND INCUBATION. IS THERE ANY POSSIBILITY DURING INOCULATION OF THE PLATES THAT CONTAMINATION COULD HAVE OCCURRED? IT IS UNLIKELY. THE CONTAMINATION IS THE SAME ORGANISMS BUT ON RANDOM PLATES FROM THE LOT. WHAT TEMPERATURE WERE THE PLATES INCUBATED AT?37C. WAS THE CONTAMINATION ON THE SURFACE OR SUB SURFACE OF THE PLATES? ON THE SURFACE, COMING OFF THE EDGE IN THE FIRST QUADRANT BUT STREAKED OUT SOME AFTER THE FIRST QUADRANT. WERE THE ORGANISMS IDENTIFIED AND IF SO WHAT WERE THEY IDENTIFIED AS? YES, BACILLUS SPECIES AND SPINGOBACTERIUM MULTIVORUM. WERE THESE ORGANISMS REPORTED OUT? YES, JUST THE SPINGOBACTERIUM MULTIVORUM WAS DESCRIBE AS GRAM NEGATIVE BACILLI AND GRAM POSITIVE BACILLUS.

    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 THAT AFTER INOCULATION AND INCUBATION, CONTAMINATION OF BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD WAS DISCOVERED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTING BLOOD AGAR PLATES 221261 PLATES WITH CONTAMINATION. CUSTOMER STATES THERE WAS NOT ANY CHANGE TO PATIENT TREATMENT DUE TO THE CONTAMINATION BEING REPORTED OUT. ADDITIONALLY, THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: PLACED FOLLOW UP CALL TO CUSTOMER TO GET MORE INFORMATION ABOUT ISSUE. THEY STATE THEY HAD SEVERAL PLATES SHOWING BACILLUS SP. AND A GRAM NEGATIVE ROD. THIS CONTAMINATION WAS SEEN AFTER THE PLATES WERE INOCULATED AND INCUBATED. THE ORGANISMS WERE NOT PRESENT ON CHOCOLATE AGAR PLATES OR ANAEROBIC PLATES. THEY STATE THE PLATES ARE RECEIVED IN THE LOADING DOCK AREA AND IMMEDIATELY BROUGHT TO THE LAB AND REFRIGERATED. THEY ARE LEFT REFRIGERATED UNTIL READY TO USE. CUSTOMER DID NOT HAVE A TOTAL PLATE COUNT OF HOW MANY INDIVIDUAL PLATES WERE AFFECTED BUT THEY STATE THEY WILL LOOK INTO THAT. THEY ARE ALSO GOING TO TRY TO GET PICTURES OF THE PLATES WITH THE CONTAMINATION ON THEM. CUSTOMER DOES NOT HAVE ANY 221261 PLATES OF THE LOT NUMBER 1050297 LEFT TO SEND IN FOR QUALITY INVESTIGATION. CAN YOU PLEASE PROVIDE THE TIME STAMP ON THE BOTTOM OF THE PLATES? UNABLE TO OBTAIN. ARE THESE SHIPPED TO YOU FROM A DISTRIBUTOR OR DIRECTLY FROM BD? DISTRIBUTOR. IF FROM A DISTRIBUTOR WHICH ONE? CARDINAL. WERE THE PLATES RECEIVED REFRIGERATED ON YOUR LOADING DOCK? YES. HOW ARE THE PLATES STORED ONCE RECEIVED AND AT WHAT TEMPERATURE? REFRIGERATED. ARE THE SLEEVES SEALED DURING STORAGE? YES. HOW MANY BOXES OF LOT 10502967 DID YOU RECEIVE?10 CASES OF 100. OUT OF THE BOXES RECEIVED OF LOT NUMBER 10502967, HOW MANY INDIVIDUAL PLATES FROM LOT DID YOU NOTICE CONTAMINATION ON? ABOUT 10-20. AS YOU STATED ON THE PHONE, THE CONTAMINATION WAS NOT NOTICED PRIOR TO INOCULATION AND INCUBATION. IS THERE ANY POSSIBILITY DURING INOCULATION OF THE PLATES THAT CONTAMINATION COULD HAVE OCCURRED? IT IS UNLIKELY. THE CONTAMINATION IS THE SAME ORGANISMS BUT ON RANDOM PLATES FROM THE LOT .WHAT TEMPERATURE WERE THE PLATES INCUBATED AT? 37C. WAS THE CONTAMINATION ON THE SUR FACE OR SUB SURFACE OF THE PLATES? ON THE SURFACE, COMING OFF THE EDGE IN THE FIRST QUADRANT BUT STREAKED OUT SOME AFTER THE FIRST QUADRANT. WERE THE ORGANISMS IDENTIFIED AND IF SO WHAT WERE THEY IDENTIFIED AS? YES, BACILLUS SPECIES AND SPINGOBACTERIUM MULTIVORUM. WERE THESE ORGANISMS REPORTED OUT? YES, JUST THE SPINGOBACTERIUM MULTIVORUM WAS DESCRIBE AS GRAM NEGATIVE BACILLI AND GRAM POSITIVE BACILLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623541 BD BBL TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 1050297

    Patients

    Seq Age Sex Outcome Treatment
    1