BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLATE CHOCOLATE BAB

    MDR report key: 20335642 · Received September 30, 2024

    Report

    Report Number
    9680577-2024-00029
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    September 2, 2024
    Report Date
    November 27, 2024
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JTY
    UDI-DI
    30382902570111
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR RECENT COMPLAINT (B)(4) REGARDING BD CHOCOLATE AGAR (BLOOD AGAR NO. 2 BASE), 20, CATALOG NUMBER 257011, LOT NUMBER UNKNOWN WITH RESPECT TO CONTAMINATION. EVENT DESCRIPTION: IT WAS REPORTED THAT MULTIPLE PLATES WERE CONTAMINATED. COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY WAS REVIEWED FOR A 12-MONTH PERIOD, AND NO SIMILAR COMPLAINT WAS IDENTIFIED FOR THIS CATALOG NUMBER. A TREND COULD NOT BE IDENTIFIED. BATCH HISTORY RECORD (BHR) REVIEW: WITHOUT A BATCH NUMBER, A BATCH HISTORY RECORD COULD NOT BE REVIEWED. SAMPLE ANALYSIS: WITHOUT A LOT NUMBER, NO RETAINMENT SAMPLES COULD BE CHECKED. RETURN SAMPLES WERE NOT PROVIDED BY THE CUSTOMER. PICTURE WAS NOT PROVIDED BY THE CUSTOMER. EVALUATION SUMMARY: AT THIS STAGE OF OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN OUR MANUFACTURING PROCESS. THIS PRODUCT DOES NOT HAVE AN SAL (STERILITY ASSURANCE LEVEL) CLAIM. IT IS FILLED ASEPTICALLY; HOWEVER, AN OCCURRENCE OF A CONTAMINATION EVENT CANNOT BE ENTIRELY RULED OUT. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION, THE COMPLAINT WAS NOT CONFIRMED FOR CONTAMINATION. A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. BD REGRETS THE INCONVENIENCES YOU HAVE EXPERIENCED DUE TO THIS ISSUE AND WILL CONTINUE MONITORING INCOMING SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. 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 · 0

    IT WAS REPORTED WHILE USING BD PLATE CHOCOLATE BAB THAT AN UNSPECIFIED NUMBER OF PLATES WERE CONTAMINATED WITH ASPERGILLUS VERSICOLOR. GROWTH APPEARED IN AREAS WHERE THE SAMPLE WAS NOT INOCULATED SO IT WAS AN OBVIOUS CONTAMINANT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLATE CHOCOLATE BAB THAT AN UNSPECIFIED NUMBER OF PLATES WERE CONTAMINATED WITH ASPERGILLUS VERSICOLOR. GROWTH APPEARED IN AREAS WHERE THE SAMPLE WAS NOT INOCULATED SO IT WAS AN OBVIOUS CONTAMINANT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2603723 BD PLATE CHOCOLATE BAB CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA JTY BECTON DICKINSON GMBH UNKNOWN 30382902570111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown