BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUTRACLEAR NEEDLE-FREE VALVE

    MDR report key: 9461651 · Received December 12, 2019

    Report

    Report Number
    9616066-2019-03658
    Event Type
    Malfunction
    Date Received
    December 12, 2019
    Report Date
    December 2, 2019
    Manufacturer
    CAIR LGL
    Product Code
    FPA
    PMA / PMN Number
    K171117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN B.5, D.4 AND D.11.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NURSE ATTACHED THE BLOOD TUBING SET TO THE PROXIMAL NEEDLE-FREE VALVE WITH THE MESA MEDICATION LINE ATTACHED TO THE DISTAL PORT. THE PATIENT WAS TO RECEIVE BLOOD TRANSFUSIONS BETWEEN THE MESA INFUSIONS. WHEN THE BLOOD TRANSFUSION WAS INITIATED, THE MESA TUBING SET AS REMOVED AND THE CAP WAS TIGHTENED. EVERYTHING LOOKED GOOD ACCORDING TO THE NURSE. WHEN THE NURSE RETURNED TO THE PATIENT'S ROOM, IT WAS NOTED THAT THE PATIENTS SHIRT WAS COVERED WITH BLOOD AND BLOOD WAS LEAKING FROM CONNECTION OF BLOOD TUBING SET AND THE NEEDLE-FREE CONNECTOR. ALTHOUGH, IT WAS REPORTED THAT PATIENT CARE WAS DELAYED IT DID NOT CONTRIBUTE TO, OR RESULT IN SERIOUS ADVERSE IMPACT TO PATIENT.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED. THE CUSTOMER¿S COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WILL NOT BE RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED. PATIENT WAS A ADULT

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE NURSE ATTACHED BLOOD TUBING TO PROXIMAL (MESA MEDICATION WAS ATTACHED TO THE DISTAL). PATIENT RECEIVED BLOOD BETWEEN MESA INFUSIONS. WHEN BLOOD WAS INITIATED, MESA LINE WAS TAKEN DOWN AND THE CAP WAS TIGHTENED. EVERYTHING LOOKED GOOD ACCORDING TO THE NURSE. WHEN SHE CAME BACK INTO THE ROOM, THE PATIENTS SHIRT WAS COVERED WITH BLOOD AND BLOOD WAS LEAKING FROM CONNECTION OF BLOOD TUBING AND CONNECTOR. ALTHOUGH, IT WAS REPORTED THAT PATIENT CARE WAS DELAYED IT DID NOT CONTRIBUTE TO, OR RESULT IN SERIOUS ADVERSE IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253319 NEUTRACLEAR NEEDLE-FREE VALVE SET, ADMINISTRATION, INTRAVASCULAR FPA CAIR LGL EL-NC1001

    Patients

    Seq Age Sex Outcome Treatment
    1 PRI TUBING