BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL CHROMAGAR ORIENTATION

    MDR report key: 20126922 · Received September 3, 2024

    Report

    Report Number
    1119779-2024-00650
    Event Type
    Malfunction
    Date Received
    September 3, 2024
    Date of Event
    August 8, 2024
    Report Date
    February 7, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JSH
    UDI-DI
    10382902150814
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY - DURING MANUFACTURING OF MATERIAL 215081, 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 FOR BATCH 4155847 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION OF EITHER BATCH. ALL BATCHES ARE TESTED PRIOR TO RELEASE AND RESULTS REPORTED ON THE CERTIFICATE OF ANALYSIS (COA) WHICH CAN BE OBTAINED AT WWW.BD.COM/REGDOCS. CHROMAGAR ORIENTATION IS STABILITY TESTED BIENNIALLY FOR BIOLOGICAL PERFORMANCE TO ENSURE SATISFACTORY PERFORMANCE THROUGHOUT SHELF LIFE WITH THE ORGANISMS THAT ARE REPORTED ON THE CERTIFICATE OF ANALYSIS. ALL PERFORMANCE TESTING ON THESE BATCHES WERE SATISFACTORY AT THE TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 4155847 FOR PERFORMANCE. RETENTION SAMPLES FOR BATCH 4155847 WERE NOT AVAILABLE FOR INSPECTION. THREE PHOTOS WERE RECEIVED, ONE PHOTO SHOWS THE PLATE FROM LOT 4155847 WITH BLUE STREAKS. THE TWO OTHER PHOTOS SHOW PLATE FROM LOT 4155847 NEXT TO ANOTHER PLATE, BOTH WITH STREAKING. PERFORMANCE RELATED ISSUES CANNOT BE CONFIRMED WITH PHOTOS. NO RETURN SAMPLES WERE RECEIVED. THIS COMPLAINT CANNOT BE CONFIRMED. NO COMPLAINT TRENDS FOR THIS DEFECT HAVE BEEN IDENTIFIED; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR THIS DEFECT.

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. 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 WHILE USING BD BBL CHROMAGAR ORIENTATION MEDIA THAT A PATIENT SAMPLE GREW E.COLI IN AN ATYPICAL BLUE COLOR AS OPPOSED TO THE EXPECTED RED-PURPLE COLOR. THE COLONY WAS SUBCULTURED AND CONFIRMED BY MALDI TOF. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BBL CHROMAGAR ORIENTATION MEDIA THAT A PATIENT SAMPLE GREW E.COLI IN AN ATYPICAL BLUE COLOR AS OPPOSED TO THE EXPECTED RED-PURPLE COLOR. THE COLONY WAS SUBCULTURED AND CONFIRMED BY MALDI TOF. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735045 BD BBL CHROMAGAR ORIENTATION CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL JSH BECTON DICKINSON & CO. (SPARKS) 4155847 10382902150814

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown