BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 24944377 · Received April 21, 2026

    Report

    Report Number
    2647876-2026-00027
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    March 23, 2026
    Report Date
    May 14, 2026
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER PHONE #: (B)(6). E.1. INITIAL REPORTER FAX #: (B)(6). THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)#: K222591 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 · 0

    IT WAS REPORTED AFTER USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS MISASSOCIATION OF ONE PATIENT SAMPLE NUMBER. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481410 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 5315067 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1