BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL CHROMAGAR ORIENTATION AND BBL TRYPTICASE SOY AGAR PLATE

    MDR report key: 11915361 · Received June 1, 2021

    Report

    Report Number
    1119779-2021-00921
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    May 4, 2021
    Report Date
    August 24, 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
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL?: YES RETURNED TO MANUFACTURER ON: 5/6/2021 INVESTIGATION: 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 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. AS MEDIA PROGRESSES THROUGH SHELF LIFE, SOME CONDENSATE WILL APPEAR INSIDE THE SLEEVES, DISHES OR ON THE AGAR SURFACE. THIS CONDENSATE OR EXCESSIVE MOISTURE OCCASIONALLY PRESENTS UPON REMOVAL FROM STORAGE AND PACKAGING. PLATES CAN BE INVERTED OVER THE LID AND ALLOWED TO DRY BEFORE INOCULATION WHEN CONDENSATE/EXCESSIVE MOISTURE IS NOTED. IT IS BEST TO DO THESE 2 TO 3 HOURS DIRECTLY BEFORE YOU INOCULATE THE PLATES (SEE WARNINGS AND PRECAUTIONS SECTION OF YOUR PRODUCT INSERT WHERE APPLICABLE). CONTROL OF THE TEMPERATURE CYCLING THAT OUR PRODUCT EXPERIENCES WHILE IN YOUR POSSESSION MAY HELP REDUCE THE AMOUNT OF FREE MOISTURE SEEN. POOLING OF WATER INSIDE THE SLEEVE IS NOT CONSIDERED A NORMAL AMOUNT OF EXCESSIVE MOISTURE. THE BATCH HISTORY RECORD FOR BATCH 1085486 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 OUR 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 TYPICAL LEVELS. 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 THIS BATCH. RETENTION SAMPLES FROM BATCH 1085486 WERE NOT AVAILABLE FOR INSPECTION. FIVE PHOTOS WERE RECEIVED FOR INVESTIGATION. ONE PHOTO SHOWS A SLEEVE FROM BATCH 1085486 WITH THE SLEEVE LABEL FEATURED FOR BATCH VERIFICATION. ANOTHER PHOTO SHOWS THE SIDE OF A SLEEVE WITH BLUE COLORED GROWTH IN THE CHROMAGAR ORIENTATION MEDIUM OF AT LEAST ONE PLATE AT THE BOTTOM. THE THIRD PHOTO SHOWS THE SURFACE OF AN OPENED BI-PLATE WITH BACTERIAL GROWTH ON EACH MEDIA. THE OTHER THE TWO PHOTOS EACH SHOW THE AGAR SURFACE OF AN OPENED BI-PLATE WITH GROWTH ON THE CHROMAGAR ORIENTATION MEDIUM ONLY. ALL GROWTH SEEN ON THE CHROMAGAR ORIENTATION IS BLUE COLORED. RETURNS ALSO WERE RECEIVED FOR INVESTIGATION. THIRTY-FOUR PLATES FROM BATCH 1085486 WERE RETURNED AND FOUR LOOSE PLATES HELD TOGETHER WITH A RUBBER BAND IN A ZIPLOCK BAG AND THREE UNOPENED SLEEVES SHIPPED IN A BOX. PLATES WERE INSPECTED AND SURFACE AND SUBSURFACE BACTERIAL GROWTH WERE OBSERVED IN 14/34 PLATES RETURNED (TIME STAMPS 0900, 0901, 0909-0911). TWO AFFECTED PLATES WERE SUBMITTED TO THE ID LAB AND PSEUDOMONAS FLUORESCENS WAS IDENTIFIED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. THIS COMPLAINT HAS BEEN CONFIRMED. CAPA#3076308 HAS BEEN INITIATED TO DETERMINE THE ROOT CAUSE AND CORRECTIVE ACTIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 3 BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR PLATE¿ FOREIGN MATTER 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 REPORTS 222239 LOT 1085486 ARRIVES WITH CONTAMINATION. "

    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 3 BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR PLATE¿ FOREIGN MATTER 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 REPORTS 222239 LOT 1085486 ARRIVES WITH CONTAMINATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808278 BD BBL CHROMAGAR ORIENTATION AND BBL TRYPTICASE SOY AGAR PLATE CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL JSH BECTON, DICKINSON & CO. (SPARKS) 222239 1085486 10382902222399

    Patients

    Seq Age Sex Outcome Treatment
    1