BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL CHROMAGAR ORIENTATION AND BBL TRYPTICASE SOY AGAR W/5% SHEEP BLOOD PLATE

    MDR report key: 11616947 · Received April 5, 2021

    Report

    Report Number
    1119779-2021-00609
    Event Type
    Malfunction
    Date Received
    April 5, 2021
    Date of Event
    March 11, 2021
    Report Date
    September 16, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSH
    UDI-DI
    10382902222399
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY : DURING MANUFACTURING OF MATERIAL 222239, 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 BATCHES 0365601 AND 0345703 WERE SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION OF EITHER BATCH . 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 THESE BATCHES WERE 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 ONE OTHER COMPLAINT HAS BEEN TAKEN ON BATCH 0365601 FOR CONTAMINATION FROM ANOTHER CUSTOMER. FOR BATCH 0345703, THE ONLY OTHER COMPLAINTS TAKEN WERE FROM THIS CUSTOMER FOR DIFFERENT DEFECTS AND/OR SHIPMENTS. RETENTION SAMPLES FROM BATCHES 0365601 AND 0345703 WERE NOT AVAILABLE FOR INSPECTION. FIVE PHOTOS WERE RECEIVED FOR INVESTIGATION. ONE PHOTO SHOWS TWO STACKS OF BI-PLATES WITH LABELS APPLIED BUT NO CONTAMINATION IS OBSERVABLE. ONE PHOTO SHOWS THE BOTTOM OF TWO PLATES FROM BATCH 0365601 (TIME STAMP NOT READABLE) WITH MICROBIAL GROWTH VISIBLE IN THE CHROMAGAR ORIENTATION MEDIUM OF ONE PLATE. ONE PHOTO SHOWS THE BOTTOM OF THREE PLATES FROM BATCH 0365601 (TIME STAMP NOT READABLE) WITH MICROBIAL GROWTH IN AT LEAST ONE MEDIUM OF EACH PLATE. ONE PHOTO SHOWS THE BOTTOM OF FOUR PLATES FROM BATCH 0345703 (TIME STAMP 1100) WITH MICROBIAL GROWTH IN ONE MEDIUM OF EACH PLATE. ONE PHOTO SHOWS THE BOTTOM OF TWO PLATES FROM BATCH 0345703 (TIME STAMPS 1345 AND 1402) WITH MICROBIAL GROWTH IN ONE MEDIUM OF EACH PLATE. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. DUE TO THE NUMBER OF COMPLAINTS TAKEN FOR CONTAMINATION FOR MATERIAL 222239, A CAPA (CORRECTIVE AND PREVENTATIVE ACTIONS) 3076308 HAS BEEN INITIATED TO DETERMINE THE ROOT CAUSE OF AND CORRECTIVE ACTIONS FOR THE CONTAMINATION. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR W/5% SHEEP BLOOD (TSA II)-I PLATE¿ 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: "CUSTOMER PROBLEM: CUSTOMER REPORTING CONTAMINATION WITH 222239 PLATES LOTS 0345703 AND 0365601 IF MEDIA PERFORMANCE ISSUE PROVIDE ORGANISM ATCC STRAIN INFORMATION (IF APPLICABLE): N/A STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER SENT EMAIL STATING THEY HAD CONTAMINATION ON 26 PLATES OF 222239. 2 PLATES FROM LOT 0345703 HAD FUNGAL CONTAMINATION, 17 PLATES FROM LOT 0345703 HAD BACTERIAL CONTAMINATION AND 7 PLATES FROM LOT 0365601 HAD BACTERIAL CONTAMINATION. ALL CONTAMINATION WAS ON THE SURFACE AND NOTICED BEFORE INOCULATION. THE CONDITION UPON RECEIPT WAS ACCEPTABLE AND THE CONTAMINATION WASN¿T NOTICED UNTIL THE BOXES WERE OPENED. PRODUCT IS STORED IN REFRIGERATOR UPON ARRIVAL AND SLEEVES REMAIN SEALED UNTIL USE. CUSTOMER DOES NOT HAVE ANY AFFECTED PRODUCT REMAINING FOR INVESTIGATION AND THEREFORE NO RETURNS ARE REQUESTED. THEY ARE NOT REQUESTING REPLACEMENTS OR CREDIT FOR THIS ISSUE."

    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. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0345703. MEDICAL DEVICE EXPIRATION DATE: 2021-03-10 . DEVICE MANUFACTURE DATE: 2020-12-10 . MEDICAL DEVICE LOT #: 0365601. MEDICAL DEVICE EXPIRATION DATE: 2021-03-29. DEVICE MANUFACTURE DATE:2020-12-30.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR W/5% SHEEP BLOOD (TSA II)-I PLATE¿ 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: "CUSTOMER PROBLEM: CUSTOMER REPORTING CONTAMINATION WITH 222239 PLATES LOTS 0345703 AND 0365601 IF MEDIA PERFORMANCE ISSUE PROVIDE ORGANISM ATCC STRAIN INFORMATION (IF APPLICABLE): N/A STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER SENT EMAIL STATING THEY HAD CONTAMINATION ON 26 PLATES OF 222239. 2 PLATES FROM LOT 0345703 HAD FUNGAL CONTAMINATION, 17 PLATES FROM LOT 0345703 HAD BACTERIAL CONTAMINATION AND 7 PLATES FROM LOT 0365601 HAD BACTERIAL CONTAMINATION. ALL CONTAMINATION WAS ON THE SURFACE AND NOTICED BEFORE INOCULATION. THE CONDITION UPON RECEIPT WAS ACCEPTABLE AND THE CONTAMINATION WASN¿T NOTICED UNTIL THE BOXES WERE OPENED. PRODUCT IS STORED IN REFRIGERATOR UPON ARRIVAL AND SLEEVES REMAIN SEALED UNTIL USE. CUSTOMER DOES NOT HAVE ANY AFFECTED PRODUCT REMAINING FOR INVESTIGATION AND THEREFORE NO RETURNS ARE REQUESTED. THEY ARE NOT REQUESTING REPLACEMENTS OR CREDIT FOR THIS ISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514144 BD BBL CHROMAGAR ORIENTATION AND BBL TRYPTICASE SOY AGAR W/5% SHEEP BLOOD PLATE CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL JSH BECTON, DICKINSON & CO. (SPARKS) 222239 SEE H.10 10382902222399

    Patients

    Seq Age Sex Outcome Treatment
    1