BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ MACCONKEY II AGAR

    MDR report key: 14228880 · Received April 27, 2022

    Report

    Report Number
    1119779-2022-00628
    Event Type
    Malfunction
    Date Received
    April 27, 2022
    Date of Event
    April 4, 2022
    Report Date
    August 29, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSI
    UDI-DI
    10382902212703
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: PRODUCT COMPLAINT DURING MANUFACTURING OF MATERIAL 221270, 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 WAS REVIEWED FOR BATCH 2033845 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, AND TWO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 2033845 FOR CONTAMINATION. NO RETENTION SAMPLES FOR THIS BATCH WERE AVAILABLE FOR INVESTIGATION. THREE PHOTOS WERE RECEIVED. PHOTOS ONE, TWO, AND THREE SHOW RED COLONIES ON PLATES WITH LOT NUMBER 2033845 AND TIMESTAMPS AT 0812, 0810, AND 0811 RESPECTIVELY. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION OF THIS COMPLAINT. THIS COMPLAINT CAN BE CONFIRMED. NO COMPLAINT TRENDS FOR CONTAMINATION HAVE BEEN IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. RISK MANAGEMENT FILE REVIEW ASSESSED THE POTENTIAL RISK FOR THE DEFECT AS SEVERITY 1, PER BALTRMPPMSELECTIVEAPH, REV 02, ID 6.13.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD BBL¿ MACCONKEY II AGAR HAS BEEN FOUND EXPERIENCING EIGHT OCCURRENCES OF BIOLOGICAL CONTAMINATION. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROBLEM: CUSTOMER REPORTS CONTAMINATED PLATES FOR CAT 221270 LOT 2033845. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: THIS IS CARDINAL CASE NUMBER (B)(4). FOLLOWED UP WITH CUSTOMER AND THEY HAVE CLARIFIED THAT 8 SLEEVES AFFECTED, NOT 8 PACKS/BOXES. PRODUCT WAS RECEIVED REFRIGERATED AND STORED IN THEIR WALK-IN FRIDGE. CUSTOMER HAS NOT PERFORM ANY GRAM STAIN ON THE CONTAMINATION AS PLATES ARE PROMPTLY DISCARDED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD BBL¿ MACCONKEY II AGAR HAS BEEN FOUND EXPERIENCING EIGHT OCCURRENCES OF BIOLOGICAL CONTAMINATION. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROBLEM: CUSTOMER REPORTS CONTAMINATED PLATES FOR CAT 221270 LOT 2033845. -STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: THIS IS CARDINAL CASE NUMBER (B)(4). FOLLOWED UP WITH CUSTOMER AND THEY HAVE CLARIFIED THAT 8 SLEEVES AFFECTED, NOT 8 PACKS/BOXES. PRODUCT WAS RECEIVED REFRIGERATED AND STORED IN THEIR WALK-IN FRIDGE. CUSTOMER HAS NOT PERFORM ANY GRAM STAIN ON THE CONTAMINATION AS PLATES ARE PROMPTLY DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1540955 BD BBL¿ MACCONKEY II AGAR CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON, DICKINSON & CO. (SPARKS) 221270 2033845 10382902212703

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown