BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD

    MDR report key: 15841249 · Received November 22, 2022

    Report

    Report Number
    1119779-2022-01413
    Event Type
    Malfunction
    Date Received
    November 22, 2022
    Date of Event
    November 9, 2022
    Report Date
    February 14, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSJ
    UDI-DI
    10382902213533
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: DURING MANUFACTURING OF MATERIAL 221353, 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 REVIEW FOR BATCH 2250542 WAS SATISFACTORY 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, AN NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 2250542. NO RETENTION SAMPLES FOR THIS BATCH WERE AVAILABLE FOR INVESTIGATION. SIX PHOTOS WERE RECEIVED. PHOTO ONE SHOWS ONE PLATE (ID 2250542 TIMESTAMP 2355) WITH MULTIPLE SMALL COLONIES. PHOTO TWO SHOWS ONE PLATE SHOWING 2 COLONIES AND NO ID. PHOTO THREE SHOWS ONE PLATE WITH TWO COLONIES AND NO ID. PHOTO THREE SHOWS THREE PLATES WITH MULTIPLE COLONIES ON EACH PLATE (ID (B)(6)TIMESTAMP 2355, ID (B)(6) TIMESTAMP 2355 AND ID UNREADABLE TIMESTAMP 2355). PHOTO FOUR SHOWS ONE PLATE WITH ONE COLONY (ID (B)(6) TIMESTAMP 2355). PHOTO FIVE SHOWS TWO PLATES WITH CONTAMINATION. ONE PLATE SHOWS NO VISIBLE ID, SECOND PLATE ID 2250542 TIMESTAMP 2355). NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION OF THIS COMPLAINT. THIS COMPLAINT CAN BE CONFIRMED. BD HAS IDENTIFIED A CONTAMINATION TREND FOR THIS PRODUCT AND THE INVESTIGATION FOUND OPPORTUNITIES FOR BIOBURDEN REDUCTION IN THE MANUFACTURING PROCESS. ADDITIONAL TRAININGS ARE PLANNED WITH AN ONGOING TRAINING REVIEW FOR CLEANING PROCESSES.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD CONTAMINATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTAMINATED PLATES WITH LOT #2250542.

    Description of Event or Problem · 0

    IT WAS REPORTED BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD CONTAMINATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTAMINATED PLATES WITH LOT #2250542.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2781454 BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL JSJ BECTON, DICKINSON & CO. (SPARKS) 221353 2250542 10382902213533

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown