BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE BBL CHROMAGAR CANDIDA 100MM

    MDR report key: 12461447 · Received September 13, 2021

    Report

    Report Number
    9614033-2021-00104
    Event Type
    Malfunction
    Date Received
    September 13, 2021
    Date of Event
    August 16, 2021
    Report Date
    September 21, 2021
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    JSI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A CLAIM WAS RECEIVED FOR CATALOG 252630 LOT 1182816 AND CATALOG 252631 UNKNOWN LOT FROM THE CLIENT SALUD DIGNA CULIACAN. THE RETENTION SAMPLES WERE REVIEWED WITHOUT FINDING A PRODUCT MIXTURE, THE PHOTOGRAPHS SENT BY THE CUSTOMER WERE REVIEWED WITHOUT DETECTING A PRODUCT MIXTURE. THE PRODUCTION PROGRAM OF THE PRODUCTION AREA WAS REVIEWED AND IT WAS IDENTIFIED THAT THE REPORTED BATCH 252630-1182816 BEGAN AND ENDED ITS PRODUCTION ON THURSDAY, (B)(6) 2021. ACCORDING TO THE INFORMATION SHOWN IN THE TABLE, THERE ARE SEVEN BATCHES OF PRODUCT PRODUCED BEFORE THE CHROMAGAR CANDIDA REPORTED AND THE CLOSEST CHOMAGAR ORIENTATOR, AMONG THESE BATCHES IT IS OBSERVED THAT FOUR OF THEM CORRESPOND TO COLORED MEDIA, SO THE PRESENCE OF A PRODUCT WITH OTHER CHARACTERISTICS MUST HAVE BEEN VERY EVIDENT DURING THE LINE CLEARANCE PROCESS. IT IS ALSO OBSERVED THAT AFTER PRODUCTION THE REPORTED BATCH TOOK EIGHT DAYS FOR THE NEXT PRODUCTION OF A ORIENTATOR CHROMAGAR WITH AT LEAST FIVE COLORED INTERMEDIATE BATCHES. THE RETENTION SAMPLES WERE RECOVERED WITHOUT DETECTING THE DEFECT REPORTED BY THE CUSTOMER. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PLATE BBL CHROMAGAR CANDIDA 100MM, THE DEVICE EXPERIENCED MIX OF PRODUCT. THIS EVENT OCCURRED TEN TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: BAG WITH PLATES OF TWO DIFFERENT CODES. USER DOES NOT INDICATE FURTHER INFORMATION. AT THE TIME OF FILLING IN THE STACKERS OF THE SORTERA IN THE (B)(6) TEAM WE HAVE NOTICED ON TWO OCCASIONS THAT THE CHROMAGAR ORIENTATOR SHELL PACK CONTAINS CHROMAGAR CANDIDA PLATES, THAT IS, IN A FIRST BAG THEY CONTAINED 2 ORIENTATOR CHROMAGAR PLATES AND 8 OF CHROMAGAR CANDIDA, AND IN THE SECOND BAG THEY CONTAINED 8 PLATES OF ORIENTATOR CHROMAGAR AND 2 OF CHROMAGAR CANDIDA.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD PLATE BBL CHROMAGAR CANDIDA 100MM, THE DEVICE EXPERIENCED MIX OF PRODUCT. THIS EVENT OCCURRED TEN TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: BAG WITH PLATES OF TWO DIFFERENT CODES. USER DOES NOT INDICATE FURTHER INFORMATION. AT THE TIME OF FILLING IN THE STACKERS OF THE SORTERA IN THE KIESTRA TEAM WE HAVE NOTICED ON TWO OCCASIONS THAT THE CHROMAGAR ORIENTATOR SHELL PACK CONTAINS CHROMAGAR CANDIDA PLATES, THAT IS, IN A FIRST BAG THEY CONTAINED 2 ORIENTATOR CHROMAGAR PLATES AND 8 OF CHROMAGAR CANDIDA, AND IN THE SECOND BAG THEY CONTAINED 8 PLATES OF ORIENTATOR CHROMAGAR AND 2 OF CHROMAGAR CANDIDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360960 PLATE BBL CHROMAGAR CANDIDA 100MM CULTURE MEDIA JSI BECTON DICKINSON DE MEXICO 1182816

    Patients

    Seq Age Sex Outcome Treatment
    1