BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    MDR report key: 22547537 · Received July 18, 2025

    Report

    Report Number
    2647876-2025-00078
    Event Type
    Malfunction
    Date Received
    July 18, 2025
    Date of Event
    October 9, 2023
    Report Date
    June 11, 2025
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    . G5. ADDITIONAL 510(K): K222591 H4. DEVICE MANUFACTURE DATE: UNKNOWN INVESTIGATION SUMMARY: CUSTOMER REPORTED A MOLECULAR FALSE POSITIVE RESULT. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. BD WAS NOT ABLE TO PERFORM AN INVESTIGATION TO THE RETENTION SAMPLES SINCE BATCH NUMBER IS UNKNOWN. A COMPLAINT HISTORY REVIEW CANNOT BE CONDUCTED RELATING TO THE INCIDENT LOT NUMBER AND THE ¿AS REPORTED¿ DEFECT CODE SINCE BATCH NUMBER IS UNKNOWN. THE BATCH HISTORY RECORD COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN NONETHELESS BATCH HISTORY RECORDS ARE ALWAYS REVIEWED PRIOR TO PRODUCT RELEASE. COMPLAINT IS UNCONFIRMED. NO CORRECTIVE ACTIONS WERE REQUIRED. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATIONAL PROCESS. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023¿2025, UNDER CAPA 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS A MOLECULAR FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401500 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. UNKNOWN 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown