BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ AST INDICATOR SOLUTION

    MDR report key: 15906398 · Received December 2, 2022

    Report

    Report Number
    1119779-2022-01456
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    November 23, 2022
    Report Date
    January 30, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382902460030
    PMA / PMN Number
    K020321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 AND LOW FILL OF PHOENIX AST BROTH TUBE (246003) BATCH 2082249. THE AFFECTED TUBES ARE CLOUDY AND LOW FILL. BASED OFF THE PHOTO AND RETURNS PROVIDED FOR THE INVESTIGATION, THIS COMPLAINT IS CONFIRMED. A ROOT CAUSE WAS NOT DETERMINED. A REVIEW OF QUALITY NOTIFICATIONS REVIEWED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED ONE OTHER COMPLAINTS ON THIS BATCH RELATED TO THIS DEFECT. 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. THE FOLLOWING ARE GUIDELINES TO HELP MINIMIZE PHOENIX AST ISSUES: MEDIA SELECTION ISOLATES MUST BE RECOVERED FROM NON-SELECTIVE MEDIA. SEE TABLE 16 RECOMMENDED MEDIA IN THE BD USER MANUAL FOR A LIST OF RECOMMENDED MEDIA. ENSURE QUALITY OF VENDOR SELECTION FOR PLATED MEDIA. VARIATIONS IN FORMULATIONS MAY IMPACT RESULTS. CULTURE HANDLING CULTURES MUST BE 18-24 HOURS OLD FOR GRAM-NEGATIVE & GRAM-POSITIVE ORGANISMS AND 18-48 HOURS OLD FOR YEAST ORGANISMS. FOR QC ORGANISMS, ENSURE ORGANISMS HAVE BEEN SUBCULTURED AT LEAST TWICE ON TWO CONSECUTIVE DAYS ON PROPER NONSELECTIVE MEDIA (GRAM-NEGATIVE OR GRAM-POSITIVE ORGANISMS: TSA WITH 5% SHEEP BLOOD, YEAST: SABOURAUD DEXTROSE AGAR). MCFARLAND PREPARATION USE OF A LOW-QUALITY STERILE COTTON SWAB, WHICH SHED FIBERS, COULD POTENTIALLY CONTRIBUTE TO A FALSELY HIGH MCFARLAND READING. POLYESTER SWABS ARE NOT RECOMMENDED. ENSURE BD APPROVED NEPHELOMETER IS ADEQUATELY CALIBRATED WITH NOT EXPIRED MCFARLAND CALIBRATION TUBES. PREPARED TUBES SHOULD BE VORTEXED FOR 5 SECONDS AND ALLOWED APPROXIMATELY 10 SECONDS FOR AIR BUBBLES TO SURFACE. ENSURE MCFARLAND FALLS WITHIN PROPER RANGE OF THE INOCULUM DENSITY. FOR 0.5 MCFARLAND SYSTEM, 0.50-0.60 IS ACCEPTABLE. FOR 0.25 MCFARLAND SYSTEM, 0.20-0.30 IS ACCEPTABLE. FOR YEAST PANELS, 2.00-2.40 IS ACCEPTABLE. CONFIRM CURRENT INSTRUMENT SETTINGS FOR INOCULUM DENSITY BEFORE INOCULATING PANELS. FOR EXAMPLE, ENSURE A 0.50 MCFARLAND WAS NOT PREPARED FOR A 0.25 INOCULUM DENSITY INSTRUMENT SETTING. USE BACTERIAL SUSPENSIONS WITHIN 60 MINUTES OF PREPARATION. PANEL PREPARATION PANELS SHOULD BE USED WITHIN 2 HOURS OF REMOVAL FROM POUCH. INOCULATE PANELS WITHIN 30 MINUTES OF THE TIME THAT THE AST BROTH INOCULUM IS PREPARED. ALLOW SUFFICIENT TIME FOR FLUID TO TRAVERSE DOWN THE WELL TRACKS BEFORE MOVING THE PANEL. AVOID TOUCHING THE FRONT AND BACKSIDE OF THE PANEL. HANDLE PANELS BY THE SIDES TO AVOID PRODUCING SMUDGES ON THE SURFACE OF THE PANELS. INOCULATED PANELS SHOULD BE HANDLED WITH CARE. AVOID KNOCKING OR JARRING THE PANEL. LOAD PANELS INTO INSTRUMENT WITHIN 30 MINUTES OF INOCULATION.

    Additional Manufacturer Narrative · 0

    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 BD PHOENIX¿ AST INDICATOR SOLUTION CONTAMINATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AST BROTH TUBES ARE CONTAMINATED , TURBID , AND LOW IN VOLUME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PHOENIX¿ AST INDICATOR SOLUTION CONTAMINATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AST BROTH TUBES ARE CONTAMINATED , TURBID , AND LOW IN VOLUME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349123 BD PHOENIX¿ AST INDICATOR SOLUTION SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) 246003 2082249 30382902460030

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown