BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ (TSA II)-I PLATE¿

    MDR report key: 11967811 · Received June 9, 2021

    Report

    Report Number
    1119779-2021-00980
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    May 12, 2021
    Report Date
    November 8, 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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    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 1106169 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 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 OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 1106169 FOR CONTAMINATION AND OTHER DEFECTS INCLUDING FROM (B)(6) REFERENCE LAB (COMPLAINT (B)(4)). RETENTION SAMPLES FROM BATCH 1106169 WERE NOT AVAILABLE FOR INSPECTION. RETURNS WERE RECEIVED FOR INVESTIGATION. A TOTAL OF 103 PLATES FROM BATCH 1106169 WERE RETURNED AS SIX UNOPENED SLEEVES (60 PLATES) AND 43 LOOSE PLATES TAPED TOGETHER ALL SHIPPED IN A BOX WITH AIR BUBBLES (TIME STAMPS 1350, 1351, 1355, 1358, 1402, 1404, 1423, 1426, 1433, 1434, 1438, 1441, 1444, 1445, 1450-1453, 1455, 1457, 1502, 1512, 1518, 1520, 1530-1534, 1536, 1542, 1543) . IT IS NOTED THAT NINE PLATES FROM BATCH 1106174 ALSO WERE RECEIVED WITH THESE RETURNS BUT IT WAS CLARIFIED THAT THERE WAS NO DEFECT ALLEGED BATCH 1106174. BACTERIAL GROWTH WAS OBSERVED IN 12/103 RETURNED PLATES. TWO OF THE AFFECTED PLATES WERE SUBMITTED TO THE ID LAB AND PSEUDOMONAS FLUORESCENS WAS IDENTIFIED. THREE PHOTOS ALSO WERE RECEIVED FOR INVESTIGATION. TWO PHOTOS EACH SHOW THE BOTTOM OF A TAPED PLATE FROM BATCH 1106169 (TIME STAMPS 1501 AND 1529) WITH MICROBIAL GROWTH VISIBLE IN ONE OF THE MEDIA. THE LAST PHOTO SHOWS A SLEEVE FROM BATCH 1106169 WITH THE CHROMAGAR ORIENTATION MEDIUM TURNED BLUE IN ONE PLATE (PRESUMABLY FROM MICROBIAL GROWTH). THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION. DUE TO THE NUMBER OF COMPLAINTS TAKEN FOR CONTAMINATION FOR MATERIAL 222239, A CAPA (CORRECTIVE AND PREVENTATIVE ACTIONS) (B)(4) HAS BEEN INITIATED TO DETERMINE THE ROOT CAUSE AND CORRECTIVE ACTIONS OF THE CONTAMINATION. BD WILL CONTINUE TO TREND COMPLAINTS FOR THESE DEFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 240 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 REPORTS CONTAMINATED PLATES FOR CAT 222239 LOT 1106169."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 240 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 REPORTS CONTAMINATED PLATES FOR CAT 222239 LOT 1106169."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864313 BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ (TSA II)-I PLATE¿ CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL JSH BECTON, DICKINSON & CO. (SPARKS) 222239 1106169 10382902222399

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown