BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 13698900 · Received March 8, 2022

    Report

    Report Number
    1119779-2022-00392
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Date of Event
    February 11, 2022
    Report Date
    January 3, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSH
    UDI-DI
    10382902222399
    PMA / PMN Number
    NA
    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

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1316562. MEDICAL DEVICE EXPIRATION DATE: 2022-02-09. DEVICE MANUFACTURE DATE: 2021-11-12. MEDICAL DEVICE LOT #: 1343366. MEDICAL DEVICE EXPIRATION DATE: 2022-03-07. DEVICE MANUFACTURE DATE: 2021-12-09. MEDICAL DEVICE LOT #: 1316562. MEDICAL DEVICE EXPIRATION DATE: 2022-02-09. DEVICE MANUFACTURE DATE: 2021-11-12. MEDICAL DEVICE LOT #: 1337221. MEDICAL DEVICE EXPIRATION DATE: 2022-02-28. DEVICE MANUFACTURE DATE: 2021-12-03. MEDICAL DEVICE LOT #: 1337221. MEDICAL DEVICE EXPIRATION DATE: 2022-02-28. DEVICE MANUFACTURE DATE: 2021-12-03. MEDICAL DEVICE LOT #: 1316562. MEDICAL DEVICE EXPIRATION DATE: 2022-02-09. DEVICE MANUFACTURE DATE: 2021-11-12. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 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 RECORDS FOR BATCHES 1337221, 1316562 AND 1343366 WERE SATISFACTORY PER INTERNAL PROCEDURES. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE PHYSICAL ATTRIBUTE TESTING. A SAMPLE OF PLATES ARE INCUBATED AT 25 DEGREES C AND AT 35 DEGREES C FOR APPROXIMATELY 72 HOURS. THEY ARE TESTED FOR PHYSICAL ATTRIBUTES PRIOR TO RELEASE TO ENSURE THAT THEY CONFORM TO PRODUCT SPECIFICATIONS. ALL PHYSICAL ATTRIBUTE TESTING PERFORMED ON THIS BATCH WAS SATISFACTORY PER BD INTERNAL PROCEDURES. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 1343366. TEN PHOTOS WERE RECEIVED FOR INVESTIGATION. ONE PHOTO SHOWS THE BOTTOM OF A PLATE FROM BATCH 1337221 (TIME STAMP 0730) WITH THE PLATE PRINT FEATURED FOR BATCH VERIFICATION. THREE PHOTOS EACH SHOWS THE BOTTOM OF A PLATE FROM BATCH 1337221 (TIME STAMPS 0632, 0657 AND 1612) WITH MIXED MEDIA IN AT LEAST ONE BI-PLATE HALF. ONE PHOTO SHOWS THE BOTTOM OF A PLATE FROM BATCH 1337221 (TIME STAMP 0604) WITH A SPLIT IN THE CHROMAGAR BED VISIBLE. ONE PHOTO SHOWS THE BOTTOM OF A PLATE FROM BATCH 1316562 (TIME STAMP 2348) WITH MIXED MEDIA IN THE TSA WITH 5% SHEEP BLOOD AGAR AND WHAT APPEARS TO BE GROWTH IN THE CHROMAGAR ORIENTATION MEDIUM. ONE PHOTO SHOWS THE BOTTOM OF A PLATE FROM BATCH 1316562 (TIME STAMP 0906) WITH MIXED MEDIA IN BOTH BI-PLATE HALVES. ONE PHOTO SHOWS A TAPED STACK OF PLATES FROM BATCH 1316562 (TIME STAMP 0625) WITH CRACKED LIDS VISIBLE. ONE PHOTO SHOWS THE BOTTOM OF A PLATE FROM BATCH 1316562 (TIME STAMP 0244) WITH THE PLATE PRINT FEATURED. ONE PHOTO SHOWS THE BOTTOM OF A PLATE FROM BATCH 1346633 (TIME STAMP 1528) WITH MIXED MEDIA IN ONE BI-PLATE HALF. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION OF THIS COMPLAINT. MEDIA SPLASH OVER IS A FILLING DEFECT WHERE THE TWO MEDIA OF A BI-PLATE ARE MIXED IN AT LEAST ONE HALF OF THE BI-PLATE. THIS RESULTS IN MEDIA APPEARING DISCOLORED AND UNEVENLY FILLED HALVES OF THE BI-PLATE. THIS COMPLAINT CAN BE CONFIRMED FOR SPLIT AGAR AND MEDIA SPLASH OVER IN BATCH 1337221. THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION, MEDIA SPLASH OVER AND BROKEN PLATES IN BATCH 1316562. THIS COMPLAINT CAN BE CONFIRMED FOR MEDIA SPLASH OVER IN BATCH 1343366. NO COMPLAINT TRENDS HAVE BEEN IDENTIFIED FOR MEDIA SPLASH OVER, BROKEN PLATES OR SPLIT AGAR IN THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME FOR THOSE DEFECTS. A TREND WAS IDENTIFIED FOR CONTAMINATION AND INVESTIGATION FOUND OPPORTUNITIES FOR BIOBURDEN REDUCTION IN THE MANUFACTURING PROCESS. FOR IMMEDIATE ACTIONS, ADDITIONAL CLEANING EVENTS OF THE MANUFACTURING AREA AND EQUIPMENT HAVE BEEN IMPLEMENTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR W/5% SHEEP BLOOD (TSA II)-I PLATE¿ BIOLOGICAL CONTAMINATION WAS FOUND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT PLATES HAD DISCOLORATION. CUSTOMER ALSO PROVIDED PICTURES WHICH REVEAL BIOLOGICAL CONTAMINATION. QUANTITY RECEIVED AND QUANTITY AFFECTED: 105 RECEIVED. 68 OF LOT 1337221 WERE CRACKED. 42 OF 1316562 WERE CRACKED. 30 OF 1343366 HAD UNEQUAL FILL. 12 OF 1316562 HAD UNEQUAL FILL. 18 OF 1337221 HAD UNEQUAL FILL. 20 OF 1337221 WERE DISCOLORED, AND 30 OF 1316562 WERE DISCOLORED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR W/5% SHEEP BLOOD (TSA II)-I PLATE¿ BIOLOGICAL CONTAMINATION WAS FOUND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT PLATES HAD DISCOLORATION. CUSTOMER ALSO PROVIDED PICTURES WHICH REVEAL BIOLOGICAL CONTAMINATION. ¿ QUANTITY RECEIVED AND QUANTITY AFFECTED: (B)(4) RECEIVED. (B)(4) OF LOT 1337221 WERE CRACKED. (B)(4) OF 1316562 WERE CRACKED. (B)(4) OF 1343366 HAD UNEQUAL FILL. (B)(4) OF 1316562 HAD UNEQUAL FILL. (B)(4) OF 1337221 HAD UNEQUAL FILL. (B)(4) OF 1337221 WERE DISCOLORED, AND (B)(4) OF 1316562 WERE DISCOLORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2758973 BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR W/5% SHEEP BLOOD CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL JSH BECTON, DICKINSON & CO. (SPARKS) 222239 1337221 10382902222399

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown