BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE HELICOBACTER AGAR 90MM 20

    MDR report key: 16496479 · Received March 7, 2023

    Report

    Report Number
    1119779-2023-00237
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    February 19, 2023
    Report Date
    June 12, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LYR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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) AGAINST HELICOBACTER AGAR, MODIFIED, CATALOG NUMBER 254430, LOT NUMBER 3009313 WITH RESPECT TO NO GROWTH. EVENT DESCRIPTION: IT WAS REPORTED NO BACTERIAL GROWTH ON THE HELICOBACTER AGAR PLATES, NOT ONLY SPECIMENS, EVEN WHEN USING QC STRAINS! COMPLAINT HISTORY REVIEW: THE COMPLAINTS TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS. THERE WERE SIMILAR COMPLAINTS RECEIVED DURING THAT PERIOD ON THIS PRODUCT. HOWEVER, NO TREND WAS IDENTIFIED. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY REVIEW DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY, AND NO DEVIATIONS WERE OBSERVED. SAMPLE ANALYSIS: A PERFORMANCE TEST WAS PERFORMED ACCORDING TO THE SPECIFICATIONS OF THE CERTIFICATE OF THE ANALYSIS AND NO DEVIATION WAS OBSERVED. NEITHER RETURNS NOR PICTURES SAMPLES WERE PROVIDED. EVALUATION RESULTS: AT THIS STAGE OF OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN OUR PRODUCTION PROCESS. THE QC PERFORMANCE TEST SHOWED AN EXCELLENT GROWTH OF HELICOBACTER PYLORI DSM 10242 AFTER AN INCUBATION TIME OF 5 DAYS AT 36°C ± 1°C IN MICROAEROPHILE ATMOSPHERE. A CORRECTIVE AND PREVENTIVE ACTION WILL NOT BE IMPLEMENTED AS A TREND COULD NOT BE IDENTIFIED. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION OF THE REPORTS AND THE PERFORMED QC TEST, THE COMPLAINT WAS NOT CONFIRMED. HOWEVER, BD WILL CONTINUE TO MONITOR INCOMING SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER FACILITY NAME: (B)(6). 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 THAT WHILE USING THE PLATE HELICOBACTER AGAR 90MM 20 THAT THERE WAS NO GROWTH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NO BACTERIAL GROWTH ON THE HELICOBACTER AGAR PLATES, NOT ONLY SPECIMENS, EVEN WHEN USING QC STRAINS!"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE PLATE HELICOBACTER AGAR 90MM 20 THAT THERE WAS NO GROWTH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NO BACTERIAL GROWTH ON THE HELICOBACTER AGAR PLATES, NOT ONLY SPECIMENS, EVEN WHEN USING QC STRAINS!".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63602 PLATE HELICOBACTER AGAR 90MM 20 NA LYR BECTON, DICKINSON & CO. (SPARKS) 3009313

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown