BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II)

    MDR report key: 11667519 · Received April 14, 2021

    Report

    Report Number
    1119779-2021-00664
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Date of Event
    March 25, 2021
    Report Date
    June 1, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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: 2021-04-20 INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS IN REGARDS TO YOUR COMPLAINTS RELATED TO, CATALOG NUMBER 221261, PLATE TRYPTICASE SOY AGAR 5% SB 100EA, BATCH NUMBERS 0358291 AND 0345995, COMPLAINT# 2652797 FOR CONTAMINATION. DURING MANUFACTURING OF MATERIAL 221261, 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 BATCH 0358291 AND BATCH 0345995 WERE SATISFACTORY AT TIME OF RELEASE PER INTERNAL PROCEDURES. 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 THESE TWO BATCHES 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. NO OTHER COMPLAINTS WERE RECEIVED FOR BATCH 0358291 AND ONE OTHER COMPLAINT WAS RECEIVED ON BATCH 0345995 FOR CONTAMINATION. RETENTION SAMPLES FROM BATCH 0358291 AND BATCH 0345995 WERE NOT AVAILABLE FOR INVESTIGATION. FOUR PHOTOS WERE RECEIVED FOR INVESTIGATION. ONE PHOTO SHOWS A SLEEVE FROM BATCH 0345995 AND ANOTHER OTHER PHOTO SHOWS THE BOTTOM OF A PLATE FROM BATCH 0345995 (TIME STAMP 0748). THE THIRD PHOTO SHOWS A CLOSE UP OF THE SIDE OF A SLEEVE OF MEDIUM-RED GAR PLATES WHERE ONE PLATE HAS DARK RED-BROWN AGAR WITH WHAT COULD BE A COLONY GROWING ON THE AGAR SURFACE AT THE EDGE. THE LAST PHOTO SHOWS A CLOSE-UP OF THE AGAR SURFACE OF A PLATE WITH TWO LARGE SURFACE BACTERIAL COLONIES AT THE EDGE. BECAUSE BATCH VERIFICATION WAS ONLY PROVIDED FOR BATCH 0345995, THE PHOTOS WOULD ONLY BE ABLE TO CONFIRM CONTAMINATION IN BATCH 0345995 FOR LACK OF BATCH VERIFICATION OF BATCH 0358291. RETURNS ALSO WERE RECEIVED FOR INVESTIGATION. EIGHTY PLATES FROM BATCH 0345995 WERE RETURNED AS EIGHT UNOPENED SLEEVES IN AN INSULATED BOX WITH ICE PACKS (TIME STAMPS 0754-0756, 0759). PLATES WERE INSPECTED AND 18/80 PLATES HAS SURFACE BACTERIAL GROWTH. ALL COLONY MORPHOLOGY WAS THE SAME; ONE AFFECTED PLATE WAS SUBMITTED TO THE ID LAB AND PSEUDOMONAS FLUORESCENS WAS IDENTIFIED. NO RETURNS FROM BATCH 0358291 WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED FOR CONTAMINATION IN BATCH 0358291. THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION IN BATCH 0345995. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. A TREND FOR BATCH 0345995 HAS NOT BEEN IDENTIFIED, THEREFORE, THERE ARE NO ACTIONS PLANNED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) GROWTH WAS DISCOVERED IN PLATES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE WAS GROWTH IN UNOPENED SLEEVES. QUANTITY OF PLATES AFFECTED ON LOT 0345995: 1078 PLATES [8 PLATES WITH POSITIVE GROWTH (8 SEPARATE SLEEVES DISCARDED) + 1070 PLATES OF SAME LOT# QUARANTINED AND UNUSED (107 SLEEVES) = 1078 PLATES] (11 BOXES).

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0358291. MEDICAL DEVICE EXPIRATION DATE: 2021-04-12. DEVICE MANUFACTURE DATE: 2020-12-23. 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 PRIOR TO USE WITH BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) GROWTH WAS DISCOVERED IN PLATES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE WAS GROWTH IN UNOPENED SLEEVES. QUANTITY OF PLATES AFFECTED ON LOT 0345995: 1078 PLATES [8 PLATES WITH POSITIVE GROWTH (8 SEPARATE SLEEVES DISCARDED) + 1070 PLATES OF SAME LOT# QUARANTINED AND UNUSED (107 SLEEVES) = 1078 PLATES] (11 BOXES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564229 BD BBL TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 0345995

    Patients

    Seq Age Sex Outcome Treatment
    1