BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX ID BROTH

    MDR report key: 12693628 · Received October 25, 2021

    Report

    Report Number
    1119779-2021-01710
    Event Type
    Malfunction
    Date Received
    October 25, 2021
    Date of Event
    September 24, 2021
    Report Date
    October 7, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    30382902460016
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR LOW VOLUME AND CONTAMINATED PHOENIX ID BROTH TUBES (246001) BATCH 1140913. THE CUSTOMER DID RETURN A PHOTO FOR INVESTIGATION. THE PHOTO SHOWED MULTIPLE TUBES WITH LOW VOLUME BROTH AND A DEBRIS ALMOST DUST/DIRT LIKE MATERIAL ON THE OUTSIDE OF THE TUBES. BASED ON THE PHOTO PROVIDED, THIS COMPLAINT IS CONFIRMED FOR BOTH LOW VOLUME AND CONTAMINATION. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED ONE ADDITIONAL COMPLAINT ON THE COMPLAINT BATCH. A COMPLAINT TREND WAS IDENTIFIED FOR THIS DEFECT. BASED ON THE SEVERITY AND RATE, A CORRECTIVE AND PREVENTIVE ACTION (CAPA) INVESTIGATION WAS NOT INITIATED. RATHER, THIS DEFECT WILL BE EVALUATED FOR FURTHER CONTINUOUS IMPROVEMENT OPPORTUNITIES. BD ID/AST PLANT QUALITY WILL CONTINUE TO CLOSELY MONITOR TRENDS FOR THIS DEFECT, INCLUDING CHANGES IN SEVERITY AND RATE. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS. IT IS TO BE NOTED A TREND IN LOW FILL/EMPTY TUBE COMPLAINTS HAS BEEN OBSERVED FOR PHOENIX ID BROTH (246001). AS PART OF THE INVESTIGATION FOR LOW FILL, THE TUBE AND CAP WERE ANALYZED BY BD¿S PACKAGING ENGINEERING TEAM. ANALYSIS OF THE HELICAL CAP CONCLUDED THAT THERE IS AN INTERNAL THREAD MEASUREMENT WHICH IS SLIGHTLY OUT OF TOLERANCE. THIS CONDITION LEADS TO NON-UNIFORM LINER COMPRESSION WHEN THE CAP IS AFFIXED TO THE TUBE. BD IS ACTIVELY WORKING WITH THE CAP VENDOR TO DETERMINE ROOT CAUSE AND CORRECTIVE ACTIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ ID BROTH, 4 CASES OF BIOLOGICAL CONTAMINATION AND PHYSICAL DEFECTS WERE 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 ID BROTH VOLUME IS LESS THAN STANDARD VOLUME AND CONTAMINANT OCCUR ON SOME TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1587035 BD PHOENIX ID BROTH CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 246001 1140913 30382902460016

    Patients

    Seq Age Sex Outcome Treatment
    1