BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ AST BROTH

    MDR report key: 17431649 · Received August 1, 2023

    Report

    Report Number
    3008007472-2023-00008
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Date of Event
    June 20, 2023
    Report Date
    July 24, 2023
    Manufacturer
    TRIPATH IMAGING, INC
    Product Code
    LON
    UDI-DI
    30382902460030
    PMA / PMN Number
    K020321
    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 CONFIRMED. THIS COMPLAINT IS FOR CONTAMINATION OF PHOENIX AST BROTH TUBES (246003) BATCH NUMBER 2209172. THE CUSTOMER PROVIDED A PHOTO OF THE AFFECTED TUBES AND RETURNED SAMPLES FOR THE INVESTIGATION. THE PHOTOS SHOW MULTIPLE TUBES WITH BATCH NUMBER PRESENT AND CLOUDY BROTH WITHIN. THE RETURNED SAMPLES PRESENTED TUBES OF THE COMPLAINT BATCH WITH DISCOLORATION WITHIN THE BROTH. BASED OFF THE PHOTOS AND SAMPLE RETURNS, THIS COMPLAINT IS CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVIEWED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED FIVE OTHER COMPLAINTS ON BATCH 2209172, ONE OF WHICH IS RELATED TO THIS DEFECT AND ALSO CONFIRMED. COMPLAINT TRENDING WAS PERFORMED AND THERE ARE NO TRENDS ASSOCIATED WITH THIS DEFECT. BD ID/AST WILL CONTINUE TO MONITOR FOR TRENDS ASSOCIATED WITH THIS DEFECT AND TAKE ACTION AS NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USING BD PHOENIX¿ AST BROTH CONTAMINATION WAS FOUND. THIS OCCURRED 4 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, THE BROTH COLOR HAS DISCOLORED TO CLOUDY WHITE, PINK OR LIGHT RED BEFORE USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1554198 BD PHOENIX¿ AST BROTH SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON TRIPATH IMAGING, INC 2209172 30382902460030

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown