BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22922387 · Received August 29, 2025

    Report

    Report Number
    2647876-2025-00471
    Event Type
    Malfunction
    Date Received
    August 29, 2025
    Date of Event
    October 13, 2023
    Report Date
    July 10, 2025
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G.5. MULTIPLE PMA/510(K)#: K113558, K222591. INVESTIGATION SUMMARY: CUSTOMER REPORTED A CLOUDY MEDIA ISSUE. PHOTOS WERE RECEIVED. RETENTION SAMPLES WERE TESTED FOR VIABLE CONTAMINATION BY SUB-CULTURING ON TSA, CHOCOLATE, SABOURAUD AND SCHAEDLER AGARS PLATES, VOLTAGE OUTPUT AND GRAM STAIN. ALL RESULTS WERE SATISFACTORY. BATCH HISTORY RECORD WAS REVIEWED. A COMPLAINT HISTORY REVIEW WAS CONDUCTED AND ONLY THE CURRENT COMPLAINT WAS FOUND RELATING THE INCIDENT TO THE LOT NUMBER. COMPLAINTS IS CONFIRMED AS COSMETIC/ANNOYANCE BASED ON VISUAL APPEARANCE ON RETENTION SAMPLES RESULTS. CORRECTIVE ACTIONS PREVENTIVE ACTIONS (CAPA) WAS INITIATED TO DETERMINE ANY APPROPRIATE ACTIONS TO REDUCE OCCURRENCE. BASED ON R&D EVALUATION, PRODUCT PERFORMANCE CRITERIA ARE MET. 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 A BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) BOTTLE WAS CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2837174 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3074449 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown