BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19033019 · Received April 3, 2024

    Report

    Report Number
    2647876-2024-00061
    Event Type
    Malfunction
    Date Received
    April 3, 2024
    Date of Event
    March 7, 2024
    Report Date
    March 13, 2024
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.1 INITIAL REPORTER FACILITY NAME: (B)(6). G.5 PMA / 510(K)#:K113558, K222591. H.6. INVESTIGATION SUMMARY: CATALOG 442023, BATCH NO. UNKNOWN . CUSTOMER REPORTED AN INSUFFICIENT GROWTH. 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 CORRECTIVES 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 INVESTIGATION PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THAT THERE WAS INSUFFICIENT GROWTH OF HELICOBACTER CINAEDI IN THE PLASTIC BOTTLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1448163 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