BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ AST BROTH

    MDR report key: 16463690 · Received March 1, 2023

    Report

    Report Number
    1119779-2023-00193
    Event Type
    Malfunction
    Date Received
    March 1, 2023
    Date of Event
    February 13, 2023
    Report Date
    February 14, 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
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. INVESTIGATION SUMMARY THIS COMPLAINT IS FOR A MISLABELED AND MISSING TUBE LABEL OF PHOENIX AST BROTH (246003) BATCH NUMBER 2181637. THE CUSTOMER DID NOT PROVIDE PRODUCT RETURNS BUT PROVIDED PHOTOS FOR INVESTIGATION. THE PHOTOS ILLUSTRATE TWO PHOENIX AST BROTH TUBES WITH BATCH NUMBER PRESENT, ONE HAS NO LABEL AND THE OTHER TUBE HAS TWO (2) LABELS. AS A RESULT, THIS COMPLAINT IS CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. COMPLAINT TRENDING WAS PERFORMED AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. A BD ID/AST PLANT QUALITY WILL CONTINUE TO MONITOR FOR TRENDS ASSOCIATED WITH THIS DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD PHOENIX¿ AST BROTH THAT THERE WAS LABELING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, THERE WERE TUBES WITHOUT LABELS AND TUBES WITH 2 LABELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1436270 BD PHOENIX¿ AST BROTH SEE H.10 LON BECTON, DICKINSON & CO. (SPARKS) 246003 2181637 30382902460030

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown