BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ MACCONKEY II AGAR

    MDR report key: 13961048 · Received March 31, 2022

    Report

    Report Number
    1119779-2022-00483
    Event Type
    Malfunction
    Date Received
    March 31, 2022
    Date of Event
    March 7, 2022
    Report Date
    August 3, 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
    OH, 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

    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 REVIEW FOR BATCH 2013618 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE PHYSICAL ATTRIBUTE TESTING. A SAMPLE OF PLATES ARE INCUBATED AT 25 DEGREES C AND AT 35 DEGREES C FOR APPROXIMATELY 72 HOURS. THEY ARE TESTED FOR PHYSICAL ATTRIBUTES PRIOR TO RELEASE TO ENSURE THAT THEY CONFORM TO PRODUCT SPECIFICATIONS. ALL PHYSICAL ATTRIBUTE TESTING PERFORMED ON THIS BATCH WAS SATISFACTORY PER BD INTERNAL PROCEDURES. THE COMPLAINT HISTORY WAS REVIEWED, AND ONE OTHER COMPLAINT HAS BEEN TAKEN ON BATCH 2013618 FOR CONTAMINATION. RETENTION SAMPLES FROM BATCH 2013618 WERE NOT AVAILABLE FOR INVESTIGATION. THERE WERE FIVE (5) PHOTOS AVAILABLE FOR REVIEW OF THIS COMPLAINT. THE FIRST PHOTO SHOWS THE TOP VIEW OF A STACK OF SEALED PLATES, CONTAMINATION CAN BE SEEN FROM THIS VIEW. THE SECOND IMAGE SHOWS A CARTON WITH LABEL INFORMATION. (BATCH 2013618, BOX 0045, MATERIAL 221270) THE THIRD IMAGE SHOWS A SINGLE PLATE HELD UP WITH CONTAMINATION. THE BATCH INFORMATION CAN BE SEEN THROUGH THE AGAR AND CONTAMINATION. (BATCH 2013618, TIMESTAMP 0825). THE FOURTH IMAGE SHOWS A SIDE VIEW OF A SINGLE SEALED SLEEVE OF PLATES. THE PLATE 3RD FROM THE TOP HAS CONTAMINATION AROUND THE EDGE OF THE PLATE. THE FIFTH IMAGE SHOWS A SINGLE PLATE HELP UP WITH CONTAMINATION. THE BATCH INFORMATION CAN BE SEEN ON THIS PLATE THROUGH THE MEDIA. (BATCH 2013618, TIMESTAMP 0825). NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION. NO COMPLAINT TREND HAS BEEN IDENTIFIED FOR CONTAMINATION 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 S1, PER BALTRMPPMSELECTIVEAPH , REV 02, ID 6.13. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 25 BD BBL¿ MACCONKEY II AGAR CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CUSTOMER REPORTING RECEIPT OF CONTAMINATED MEDIA PLATES 221270 - PLATE MACCONKEY II AGAR LOT 2013618."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 25 BD BBL¿ MACCONKEY II AGAR CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CUSTOMER REPORTING RECEIPT OF CONTAMINATED MEDIA PLATES 221270 - PLATE MACCONKEY II AGAR LOT 2013618."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2188801 BD BBL¿ MACCONKEY II AGAR CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON, DICKINSON & CO. (SPARKS) 221270 2013618 10382902212703

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown