BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX AST BROTH

    MDR report key: 11754337 · Received April 30, 2021

    Report

    Report Number
    1119779-2021-00748
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    April 7, 2021
    Report Date
    May 12, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    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

    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: 2021-05-05 INVESTIGATION SUMMARY THIS COMPLAINT IS FOR CONTAMINATION OF PHOENIX AST BROTH ((B)(4)) BATCH 0163162. CUSTOMER PROVIDED 4 PHOTOS FOR INVESTIGATION. THE PHOTOS SHOW WHITE FOREIGN MATTER WITHIN THE BROTH. THE CUSTOMER ALSO PROVIDED THE SAMPLE FOR ANALYSIS. THE SAMPLE WAS SUBMITTED TO QC FOR IDENTIFICATION. QC IDENTIFIED IT AS MOLD, HOWEVER WAS UNABLE TO GET THE ISOLATE TO GROW SO NO FURTHER ID WAS POSSIBLE. BASED ON THE PHOTOS AND SAMPLE PROVIDED, THIS COMPLAINT HAS BEEN CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS ON THE COMPLAINT BATCH REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED THREE ADDITIONAL COMPLAINTS FOR THIS BATCH, BUT NONE DUE TO THIS DEFECT. COMPLAINT TRENDING WAS PERFORMED AND NO TRENDS WERE IDENTIFIED FOR THIS DEFECT. BD ID/AST PLANT QUALITY WILL CONTINUE TO MONITOR FOR TRENDS ASSOCIATED WITH THIS DEFECT AND TAKE ACTION AS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ AST BROTH MOLD CONTAMINATION 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: "THE CUSTOMER REPORTED THAT MOLD WAS GROWING IN ONE AST BROTH TUBE."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER FACILITY NAME. 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 BROTH MOLD CONTAMINATION 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: "THE CUSTOMER REPORTED THAT MOLD WAS GROWING IN ONE AST BROTH TUBE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650561 BD PHOENIX AST BROTH SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) 246003 0163162 30382902460030

    Patients

    Seq Age Sex Outcome Treatment
    1