BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR

    MDR report key: 17282910 · Received July 7, 2023

    Report

    Report Number
    9614033-2023-00055
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Date of Event
    June 21, 2023
    Report Date
    September 22, 2023
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    JSH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A CLAIM WAS RECEIVED FROM THE ISABU LABORATORY CLIENT WHERE CONTAMINATION WAS REPORTED IN A PLATE UNIT FROM CATALOG 252631 LOT 3122925. THE NOTIFIED BATCH FILE WAS REVIEWED, VERIFYING THAT ALL PROCESSES WERE FOLLOWED EFFECTIVELY DURING THE MANUFACTURING OF THE PRODUCT. LIKEWISE, THE BATCH WAS ANALYZED BY THE QUALITY CONTROL DEPARTMENT AND THE RESULTS WERE SATISFACTORY FOR THE RELEASE OF THE BATCH. THE RETENTION SAMPLES WERE REVIEWED WITHOUT DETECTING THE PRESENCE OF CONTAMINATION AND THE CLAIMS HISTORY WITHOUT IDENTIFYING ADDITIONAL REPORTS OF CONTAMINATION FOR THIS BATCH. IT IS CONCLUDED THAT THE EVENT REPORTED BY THE CLIENT IS CLASSIFIED AS CONFIRMED BASED ON THE PHOTOGRAPHIC EVIDENCE PROVIDED BY THE CLIENT. ACCORDING TO THE INVESTIGATION CARRIED OUT, THE EVENT COULD HAVE OCCURRED DUE TO A PROCESS FAILURE THAT COULD HAVE GENERATED SPECIFIC CONTAMINATION OF THE PRODUCT IN THE FILLING LINE, SO AWARENESS ACTIVITIES WILL BE CARRIED OUT FOR THE TEAM RESPONSIBLE FOR THE PROCESS, NO ADDITIONAL MEASURES ARE NECESSARY BECAUSE THE PRESENCE OF A CONTAMINATED UN OF THE TOTAL NUMBER OF MANUFACTURED PARTS IS ACCEPTABLE UNDER THE AQL DEFINED FOR THIS DEFECT OF 1.0.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER ADDR 1: (B)(6). 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¿ CHROMAGAR¿ ORIENTATION AGAR THERE WAS CONTAMINATION OF ONE PLATE. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ONE PLATE OUT OF THE 10 PLATES IN THE PACKAGE ARRIVED CONTAMINATED. LOT: 3122925 AND EXPIRATION DATE: JULY 25, 2023."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR THERE WAS CONTAMINATION OF ONE PLATE. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ONE PLATE OUT OF THE 10 PLATES IN THE PACKAGE ARRIVED CONTAMINATED. LOT: 3122925 AND EXPIRATION DATE: JULY 25, 2023."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2039988 BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL JSH BECTON DICKINSON DE MEXICO 3122925

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown