BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ MACCONKEY II AGAR

    MDR report key: 15029089 · Received July 15, 2022

    Report

    Report Number
    1119779-2022-00998
    Event Type
    Malfunction
    Date Received
    July 15, 2022
    Date of Event
    June 13, 2022
    Report Date
    February 22, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSI
    UDI-DI
    10382902212703
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE LOT #: 209147 WAS REPORTED, HOWEVER, THIS IS NOT A LOT NUMBER MANUFACTURED FOR THE REPORTED CATALOG NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    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. BATCH NUMBER 209147 WAS PROVIDED. MANUFACTURING RECORDS WERE REVIEWED, AND BATCH NUMBER 209147 IS NOT VALID FOR MATERIAL 221270. NO RETURN SAMPLES OR PHOTOS WERE RECEIVED FOR INVESTIGATION. RETENTION SAMPLES CANNOT BE EVALUATED WITHOUT A SPECIFIC BATCH NUMBER. TRENDING REVIEW SHOWS THAT A CONTAMINATION TREND INCLUDING MATERIAL 221270 WAS IDENTIFIED. IF THE BATCH OF MATERIAL 221270 IN QUESTION WAS NOT EXPIRED AT THE TIME THE COMPLAINT WAS TAKEN, THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION BASED ON THE IDENTIFIED TREND. THE INVESTIGATION OF THE TREND 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. IMPROVEMENT IN OBSERVATION OF CONTAMINATION IS EXPECTED AS THE CAPA PROGRESSES. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE, 20 BD BBL¿ MACCONKEY II AGAR PLATES WERE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROBLEM: 221270 MACCONKEY PLATES CONTAMINATION. QUANTITY RECEIVED AND QUANTITY AFFECTED: 7 CT RECEIVED, 20 PLATES CONTAMINATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE, 20 BD BBL¿ MACCONKEY II AGAR PLATES WERE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿ CUSTOMER PROBLEM: 221270 MACCONKEY PLATES CONTAMINATION. ¿ QUANTITY RECEIVED AND QUANTITY AFFECTED: 7 CT RECEIVED, 20 PLATES CONTAMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2371870 BD BBL¿ MACCONKEY II AGAR CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON, DICKINSON & CO. (SPARKS) 221270 SEE H10 10382902212703

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown