BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ ID BROTH

    MDR report key: 15675529 · Received October 26, 2022

    Report

    Report Number
    1119779-2022-01330
    Event Type
    Malfunction
    Date Received
    October 26, 2022
    Date of Event
    October 17, 2022
    Report Date
    November 21, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    30382902460016
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: THIS COMPLAINT IS NOT CONFIRMED. THIS COMPLAINT IS FOR MISSING LABELS ON TUBES OF PHOENIX ID BROTH (246001) BATCH NUMBER 2132650. THE CUSTOMER DID NOT PROVIDE PHOTOS OR PRODUCT RETURNS FOR INVESTIGATION. TO INVESTIGATE, THE RETENTION BOX OF THE COMPLAINT BATCH WAS VISUALLY AND MANUALLY INSPECTED FOR THE PRESENCE OF LABELS ON TUBES. THE INSPECTION REVEALED 0/100 TUBES WITH DEFECTS IN LABELING. BASED OFF THE INVESTIGATION, THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATION GENERATED ON THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS WAS PERFORMED AND REVEALED NO ADDITIONAL COMPLAINTS 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. PLEASE CONTINUE TO COMMUNICATE ADDITIONAL CONCERNS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ ID BROTH LABELS WERE MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS A REPORT ABOUT MISSING LABELS. ACCORDING TO THE CUSTOMER'S REPORT, THERE WERE 2 TUBES WITHOUT LABELS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ ID BROTH LABELS WERE MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS A REPORT ABOUT MISSING LABELS. ACCORDING TO THE CUSTOMER'S REPORT, THERE WERE 2 TUBES WITHOUT LABELS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2510476 BD PHOENIX¿ ID BROTH CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 246001 2132650 30382902460016

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown