BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR)

    MDR report key: 12954160 · Received December 7, 2021

    Report

    Report Number
    1119779-2021-01921
    Event Type
    Malfunction
    Date Received
    December 7, 2021
    Date of Event
    November 10, 2021
    Report Date
    April 7, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    10382902212833
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES D.9. RETURNED TO MANUFACTURER ON: 24-NOV-2021 H.6. INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE FINDINGS REGARDING THE COMPLAINT RELATED TO CATALOG NUMBER 221823, PLATE TRYPTICASE SOY AGAR 100 EA, BATCH NUMBERS 1223805 AND 1259734 FOR CONTAMINATION. DURING MANUFACTURING OF MATERIAL 221283, 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 1223805 AND 1259734 WERE 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 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 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 NO OTHER COMPLAINTS HAVE BEEN TAKEN ON EITHER BATCH 1223805 OR 1259734. RETENTION SAMPLES FROM BATCH 1223805 AND 1259734 WERE NOT AVAILABLE FOR INSPECTION. TEN PLATES FROM BATCH 1223805 WERE RETURNED AS ONE UNOPENED SLEEVE IN A BOX WITH AIR BUBBLES AND BUBBLE WRAP. PLATES WERE INSPECTED AND NO MICROBIAL GROWTH WAS OBSERVED IN 10/10 RETURNED PLATES (TIME STAMP 0912). AFTER INSPECTION, RETURNED PLATES WERE INCUBATED AT 20 TO 25 DEGREES C, AND 0/10 PLATES HAD MICROBIAL GROWTH AT 7 DAYS INCUBATION. NO RETURN SAMPLES WERE RECEIVED FROM BATCH 1259734. FOUR PHOTOS ALSO WERE RECEIVED FOR INVESTIGATION. TWO PHOTOS EACH SHOW THE AGAR SURFACE OF A PLATE FROM BATCH 1259734 (TIME STAMP 1252) WITH SURFACE FUNGAL GROWTH. THE OTHER TWO PHOTOS EACH SHOW THE BOTTOM OF A PLATE FROM BATCH 1223805 (TIME STAMP 1045) WITH FUNGAL GROWTH. RETURN SAMPLES FROM BATCH 1223805 DID NOT SHOW CONTAMINATION AND NO SAMPLES WERE RECEIVED FROM BATCH 1259734. HOWEVER, THE COMPLAINTS CAN BE CONFIRMED BY THE PHOTOS PROVIDED. IT IS NOTED THAT THE CONTAMINATION WAS NOTED BY MYLAN AFTER USE AND THAT THIS PRODUCT DOES NOT HAVE A STERILE CLAIM. BASED ON THE LOW DEFECT RATE FOR THE BATCHES IN QUESTION; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. SEE H.10.

    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 #: 1259734, MEDICAL DEVICE EXPIRATION DATE: 2022-01-10, DEVICE MANUFACTURE DATE: 2021-09-16. MEDICAL DEVICE LOT #: 1223805, MEDICAL DEVICE EXPIRATION DATE: 2021-12-06, DEVICE MANUFACTURE DATE: 2021-08-11. 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 BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) PLATES WERE CONTAMINATED WITH FUNGUS. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT PLATES ARE CONTAMINATED. HOW MANY INDIVIDUAL PLATES HAD OBSERVABLE CONTAMINATION? CUSTOMER STATES ABOUT 50% OF THE PLATES THEY HAVE TESTED SO FAR. THEY CAN NOT PROVIDE AN EXACT COUNT OF AFFECTED PLATES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) PLATES WERE CONTAMINATED WITH FUNGUS. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT PLATES ARE CONTAMINATED. HOW MANY INDIVIDUAL PLATES HAD OBSERVABLE CONTAMINATION? CUSTOMER STATES ABOUT 50% OF THE PLATES THEY HAVE TESTED SO FAR. THEY CAN NOT PROVIDE AN EXACT COUNT OF AFFECTED PLATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1846959 BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 221283 SEE H10 10382902212833

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown