BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ MARTIN-LEWIS AGAR

    MDR report key: 12310853 · Received August 11, 2021

    Report

    Report Number
    1119779-2021-01362
    Event Type
    Malfunction
    Date Received
    August 11, 2021
    Date of Event
    July 22, 2021
    Report Date
    March 23, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JTY
    UDI-DI
    10382902215582
    PMA / PMN Number
    K770287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: DURING MANUFACTURING OF MATERIAL 221558, 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. NO BATCH NUMBER, RETURNS OR PHOTOS WERE PROVIDED FOR INVESTIGATION. RETENTION SAMPLES CANNOT BE EVALUATED WITHOUT A SPECIFIC BATCH NUMBER. TRENDING WAS PERFORMED ON THE APPROPRIATE QUALITY DATABASES. A RECALL FOR THREE BATCHES FOR MARTIN LEWIS AGAR WAS ISSUED ON MARCH 17, 2021 FOR MISFORMULATION: MATERIAL 221558 BATCHES 0317559 AND 0345695 AND MATERIAL 221557 BATCH 0317558. NO INFORMATION PROVIDED FROM THE CUSTOMER ACKNOWLEDGES THE USE OF THE RECALL BATCHES. THE LATEST EXPIRY OF THE RECALL BATCHES WAS APRIL 06, 2021 AND THIS COMPLAINT WAS TAKEN ON JULY 22, 2021. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ MARTIN-LEWIS AGAR ATYPICAL GROWTH 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: " IT WAS REPORTED THAT THERE ARE "POOR RESULTS".

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 · 1

    IT WAS REPORTED THAT WHILE USING BD BBL¿ MARTIN-LEWIS AGAR ATYPICAL GROWTH 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: "IT WAS REPORTED THAT THERE ARE "POOR RESULTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204897 BD BBL¿ MARTIN-LEWIS AGAR CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA JTY BECTON, DICKINSON & CO. (SPARKS) 221558 UNKNOWN 10382902215582

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown