BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ MACCONKEY II AGAR

    MDR report key: 12724084 · Received October 29, 2021

    Report

    Report Number
    1119779-2021-01736
    Event Type
    Malfunction
    Date Received
    October 29, 2021
    Date of Event
    September 30, 2021
    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
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: 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 FOR BATCH 1216291 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 1216291 FOR CONTAMINATION. RETENTION SAMPLES FROM BATCH 1216291 WERE NOT AVAILABLE FOR INSPECTION. SIX PLATES FROM BATCH 1216291 WERE RETURNED AS SIX LOOSE PLATES TAPED TOGETHER IN A ZIP LOCK BAG IN A BOX WITH COTTON PADDING SHIPPED IN A BOX WITH PAPER PADDING. PLATES WERE INSPECTED AND 6/6 PLATES HAD SURFACE BACTERIAL GROWTH (TIME STAMPS 1215, 1218 AND 1219). ONE AFFECTED PLATE WAS SUBMITTED TO THE ID LAB AND PSEUDOMONAS FLUORESCENS WAS IDENTIFIED. FIVE PHOTOS ALSO WERE RECEIVED FOR INVESTIGATION. THREE PHOTOS EACH SHOW THE AGAR SURFACE OF A PLATE FROM BATCH 1216291 (TIME STAMP 1218) WITH BACTERIAL COLONIES GROWING. THE OTHER TWO PHOTOS EACH THE TOP OF AN OPENED SLEEVE FROM BATCH 1216291 (TIME STAMP 1218) WITH BACTERIAL GROWTH IN THE TOP PLATE VISIBLE. THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION. A TREND WAS IDENTIFIED FOR CONTAMINATION AND INVESTIGATION FOUND OPPORTUNITIES FOR BIOBURDEN REDUCTION IN THE MANUFACTURING PROCESS. A CAPA (CORRECTIVE AND PREVENTATIVE ACTIONS) HAS BEEN INITIATED AND INVOLVES IMPLEMENTING ADDITIONAL CLEANING EVENTS AND EVALUATION OF MANUFACTURING PROCEDURES FOCUSED ON IN-PROCESS BIOBURDEN REDUCTION. ADDITIONAL TRAININGS ARE PLANNED WITH AN ONGOING TRAINING REVIEW FOR CLEANING PROCESSES. 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.

    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 THAT WHILE USING BD BBL¿ MACCONKEY II AGAR CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. ATHERE 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: " CALL ACTIVITY COMMENT: -CUSTOMER PROBLEM: CUSTOMER REPORTS CONTAMINATION FOR PRODUCT 221270 LOT 1216291."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 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: " CALL ACTIVITY COMMENT: -CUSTOMER PROBLEM: CUSTOMER REPORTS CONTAMINATION FOR PRODUCT 221270 LOT 1216291."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1621664 BD BBL¿ MACCONKEY II AGAR CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON, DICKINSON & CO. (SPARKS) 221270 1216291 10382902212703

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown