BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTA PLUS3 BLUE

    MDR report key: 23390518 · Received October 27, 2025

    Report

    Report Number
    9610847-2025-00383
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    October 10, 2025
    Report Date
    October 28, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE REPORTED DEFECT COULD NOT BE REFUTED NOR CONFIRMED IN THE ABSENCE OF A SAMPLE. THE ROOT CAUSE CANNOT BE DETERMINED FOR AN UNCONFIRMED DEFECT. A COMPLAINT HISTORY CHECK WAS NOT PERFORMED AS THE LOT NUMBER IS UNKNOWN FOR THIS COMPLAINT. A DEVICE HISTORY RECORD REVIEW WAS NOT PERFORMED AS THE LOT NUMBER IS UNKNOWN FOR THIS COMPLAINT. A REVIEW OF THE APPLICABLE FMEA/EURA INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY IN THE RISK MANAGEMENT DOCUMENTATION.

    Description of Event or Problem · 0

    IT IS REPORTED THAT THERE WAS A TRANSFER FROM ICN 3 TO ICN 1, AND TWO ICN NURSES MOVED THIS PATIENT. AFTER I HAD MOVED MY PATIENT, I WENT TO PROVIDE CARE FOR THIS PATIENT. I IMMEDIATELY NOTICED A LOT OF BLOOD ON THE MOLTON AND ROLLER, AND UPON INSPECTION, I FOUND THAT A TAP HAD COME LOOSE FROM THE NVL.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2341957 CONNECTA PLUS3 BLUE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown