BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3103036 · Received May 9, 2013

    Report

    Report Number
    1416980-2013-11842
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    February 7, 2013
    Report Date
    April 17, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K120443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, A BATCH REVIEW COULD NOT BE CONDUCTED. SHOULD THE DEVICE AND/OR ANY ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CIRCULAR COMPONENT OF A ONE-LINK IV CONNECTOR WAS OBSERVED TO BE PUSHED DOWN WHEN FLUID WAS ADMINISTERED AND WAS IN A "STUCK" POSITION DOWN. THE CHARGE NURSE REPORTED THEY WERE ATTEMPTING TO SETUP A NEW INFUSION WHEN THE ORIGINAL INFUSION WAS DISCONNECTED. THE ONE-LINK "BUTTON," WHICH USUALLY POPS UP, REMAINED STUCK IN A "DOWN" POSITION AND WHEN IN THE DOWN POSITION THIS LEFT THE PATHWAY OPEN. ONCE THE STUCK POSITION WAS NOTICED, IT WAS DECIDED THEY COULD NOT USE THE SAME INFUSION AND A NEW LINE WAS RUN TO THE PATIENT. THE PROBLEM WAS NOTED DURING PATIENT USE; THEREFORE, THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203719 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1