BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H10

    MDR report key: 12425187 · Received September 3, 2021

    Report

    Report Number
    1119779-2021-01470
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    March 4, 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
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-03-08 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 BATCH 0365601 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 ONE OTHER COMPLAINT HAS BEEN TAKEN ON BATCH 0365601 FOR CONTAMINATION FROM ANOTHER CUSTOMER. IT IS NOTED THAT THIS CUSTOMER DOES HAVE ANOTHER COMPLAINT ON BATCH 0365601. RETENTION SAMPLES FROM BATCH 0365601 WERE NOT AVAILABLE FOR INSPECTION. RETURNS WERE RECEIVED FOR INVESTIGATION. TWENTY-TWO PLATES FROM BATCH 0365601 WERE TURNED AS TWO UNOPENED SLEEVES (20 PLATES) AND 2 LOOSE SHIPPED IN A BOX WITH FOAM PADDING (TIME STAMPS 0735, 0745 AND 0906). PLATES IN THE UNOPENED SLEEVES WERE INSPECTED AND 5/20 PLATES HAD THIN AND UNEVEN CHROMAGAR ORIENTATION AGAR BEDS AND 0/20 PLATES HAD MICROBIAL GROWTH. FOR INVESTIGATION, SOME RETURNED PLATES WERE DIVIDED AND INCUBATED AT 20 TO 25 DEGREES C (7 PLATES) AND 33 TO 37 DEGREES C (7 PLATES). NO MICROBIAL GROWTH WAS OBSERVED IN THE INCUBATED PLATES AT 3 DAYS INCUBATION. ONE OF THE LOOSE PLATES HAD SURFACE BACTERIAL GROWTH. BECAUSE THE PLATE HAD BEEN SHIPPED AS LOOSE PLATES IN A BOX, THE GROWTH OBSERVED WAS NOT IDENTIFIED. THREE PHOTOS ALSO WERE RECEIVED FOR INVESTIGATION. ONE PHOTO SHOWS THE TOP OF AN UNOPENED SLEEVE WITH WHAT APPEARS TO BE FUNGAL GROWTH ON THE CHROMAGAR ORIENTATION MEDIUM OF THE TOP PLATE. ANOTHER PHOTO SHOWS THE SLEEVE LABEL FROM BATCH 0365601 FOR BATCH VERIFICATION. THE LAST PHOTO SHOWS THE SIDE OF AN UNOPENED SLEEVE WITH MICROBIAL GROWTH ON THE CHROMAGAR ORIENTATION MEDIUM OF THE TOP PLATE. THIS COMPLAINT CAN BE CONFIRMED FOR LOW FILL AND CONTAMINATION. BD WILL CONTINUE TO TREND COMPLAINTS FOR FILL VOLUME AND CONTAMINATION. BASED ON THE LOW DEFECT RATE FOR THIS BATCH, NO ACTIONS ARE PLANNED AT THIS TIME FOR FILL VOLUME. 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 AND CORRECTIVE ACTIONS OF THE CONTAMINATION. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PLATE OF BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR W/5% SHEEP BLOOD (TSA II)-I PLATE¿ WAS CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CUSTOMER HAS ONE PLATE CONTAMINATED WITH 222239 PLATES.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE BRAND NAME: BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR W/5% SHEEP BLOOD (TSA II)-I PLATE¿. 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 A PLATE OF BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR W/5% SHEEP BLOOD (TSA II)-I PLATE¿ WAS CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CUSTOMER HAS ONE PLATE CONTAMINATED WITH 222239 PLATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322682 SEE H10 CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL JSH BECTON, DICKINSON & CO. (SPARKS) 222239 0365601 10382902222399

    Patients

    Seq Age Sex Outcome Treatment
    1