BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12388018 · Received August 30, 2021

    Report

    Report Number
    1119779-2021-01452
    Event Type
    Malfunction
    Date Received
    August 30, 2021
    Date of Event
    July 1, 2021
    Report Date
    April 19, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 1161405. D4: MEDICAL DEVICE EXPIRATION DATE: 2021-09-27. H4: DEVICE MANUFACTURE DATE: 2021-06-10. D4: MEDICAL DEVICE LOT #: 1174805. D4: MEDICAL DEVICE EXPIRATION DATE: 2021-10-11. H4: DEVICE MANUFACTURE DATE: 2021-06-23. H6: INVESTIGATION SUMMARY: 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 BATCHES 1147002, 1161405 AND 1174805 WERE SATISFACTORY AT TIME OF RELEASE AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION OF THESE BATCHES. 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 THESE BATCHES WERE 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 NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCHES 1147002, 1161405 AND 1174805. RETENTION SAMPLES FROM BATCHES 1147002, 1161405 AND 1174805 WERE NOT AVAILABLE FOR INSPECTION. NO RETURN SAMPLES OR PHOTOS WERE RECEIVED FOR INVESTIGATION OF THIS COMPLAINT. A LOG LISTING OBSERVED DEFECTS WAS PROVIDED AND INCLUDES BATCHES 1147002, 1161405 AND 1174505. WITHOUT PHOTOS OR RETURNS, THIS COMPLAINT CANNOT BE CONFIRMED FOR BROKEN PLATES IN BATCHES 1161405 AND 1174805. THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION BASED ON A COMPLAINT TREND. A TREND WAS IDENTIFIED FOR CONTAMINATION AND INVESTIGATION FOUND OPPORTUNITIES FOR BIOBURDEN REDUCTION IN THE MANUFACTURING PROCESS. A CAPA (CORRECTIVE AND PREVENTATIVE ACTIONS) 3076308 HAS BEEN INITIATED AND INVOLVES IMPLEMENTING ADDITIONAL CLEANING EVENTS AND EVALUATION OF MANUFACTURING PROCEDURES FOCUSED ON IN-PROCESS BIOBURDEN REDUCTION.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT 4 BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) WERE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS CONTAMINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) WERE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1282421 BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown