BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOTTLE PHOENIX AST-S JAPAN 3 EA

    MDR report key: 12677540 · Received October 21, 2021

    Report

    Report Number
    2243072-2021-02573
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    September 22, 2021
    Report Date
    August 22, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    LON
    PMA / PMN Number
    K050745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: THIS COMPLAINT IS NOT CONFIRMED. THIS COMPLAINT IS FOR FAILURE TO OBTAIN SUSCEPTIBILITY RESULTS WHEN USING PHOENIX AST-S INDICATOR (252253) BATCH NUMBER 1070713. THE CUSTOMER DID NOT RETURN PICTURES, LAB REPORTS, OR SAMPLE BOTTLES FOR INVESTIGATION. THE COMPLAINT BATCH WAS NOT AVAILABLE FOR INVESTIGATION DUE TO THE BATCH BEING EXPIRED AT THE TIME OF THE INVESTIGATION AND IS BEYOND OUR STABILITY TIMEFRAME. AS A RESULT, THIS COMPLAINT IS UNCONFIRMED FOR PERFORMANCE. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED THREE ADDITIONAL COMPLAINTS ON THE COMPLAINT BATCH, NONE OF WHICH WERE RELATED TO THIS ISSUE. COMPLAINT TRENDING WAS PERFORMED AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. BD ID/AST PLANT QUALITY WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS. PER BALTRMPHXIDASTAPH REV 10 VERSION H, ID 3.0-3.17, INDICATES THE POTENTIAL RISK OF NO RESULT (ID OR AST) IS S3.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BOTTLE PHOENIX AST-S JAPAN 3 EA ATYPICAL GROWTH WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ACCORDING TO THE CUSTOMER¿S REPORT, THE TEST FAILS IN OBTAINING SUSCEPTIBILITY RESULTS."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US BUT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED DEVICE BD PHOENIX¿ AST-S INDICATOR SOLUTION CATALOG NUMBER 246009 WHICH HAS 510K NUMBER K050745.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BOTTLE PHOENIX AST-S JAPAN 3 EA ATYPICAL GROWTH WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ACCORDING TO THE CUSTOMER¿S REPORT, THE TEST FAILS IN OBTAINING SUSCEPTIBILITY RESULTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1573738 BOTTLE PHOENIX AST-S JAPAN 3 EA SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON DICKINSON 1070713

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown