BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX AST-S BROTH

    MDR report key: 11634512 · Received April 8, 2021

    Report

    Report Number
    1119779-2021-00624
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    March 17, 2021
    Report Date
    April 27, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382902460078
    PMA / PMN Number
    K050745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-03-18. INVESTIGATION SUMMARY: INVESTIGATIONAL TESTING WAS PERFORMED USING THE RETURNED SAMPLE TUBE. THE RETURNED SAMPLE WAS ANALYZED BY QC AND CONTAMINATION WAS IDENTIFIED AS BACILLUS SIMPLEX. THE COMPLAINT INVESTIGATION ALSO INCLUDED A REVIEW OF QUALITY NOTIFICATIONS ON THE COMPLAINT BATCH FOR THIS DEFECT. THERE WAS ONE QUALITY NOTIFICATION ON THE COMPLAINT BATCH, HOWEVER IT WAS NOT RELATED TO THIS DEFECT. A REVIEW OF PREVIOUS COMPLAINTS WERE PERFORMED AND THERE WERE NO ADDITIONAL COMPLAINTS ON THIS BATCH. COMPLAINT TRENDING WAS PERFORMED AND NO TRENDS WERE IDENTIFIED FOR THIS BATCH OR DEFECT. NO FURTHER CORRECTIVE ACTION IS REQUIRED BECAUSE NO COMPLAINT TRENDS EXIST. THE FOLLOWING FIELDS WERE UPDATED WITH CORRECTIONS: B.5. EVENT DESCRIPTION: IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ AST-S BROTH CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. CUSTOMER GRAM STAINED THE GROWTH, WHICH TURNED OUT TO BE OVER DECOLORIZED LARGE GRAM POSITIVE ROD (BACILLUS MORPH). 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: " CUSTOMER IS REPORTING CONTAMINATION WITH LOT 1020655."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ AST-S BROTH CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. CUSTOMER GRAM STAINED THE GROWTH, WHICH TURNED OUT TO BE OVER DECOLORIZED LARGE GRAM POSITIVE ROD (BACILLUS MORPH). 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: " CUSTOMER IS REPORTING CONTAMINATION WITH LOT 1020655."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ AST-S BROTH CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. A GRAM STAIN WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. 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: " CUSTOMER IS REPORTING CONTAMINATION WITH LOT 1020655."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532021 BD PHOENIX AST-S BROTH SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) 246007 1020655 30382902460078

    Patients

    Seq Age Sex Outcome Treatment
    1