BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, INTRAVASCULAR

    MDR report key: 5010572 · Received August 18, 2015

    Report

    Report Number
    5010572
    Event Type
    Malfunction
    Date Received
    August 18, 2015
    Date of Event
    July 29, 2015
    Report Date
    August 5, 2015
    Manufacturer
    EDWARD LIFESCIENCES LLC
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT CALLED TO SAY HE WAS BLEEDING. THE NIGHT NURSE AND I WALKED INTO THE ROOM AND DISCOVERED HE WAS BLEEDING FROM HIS RIGHT RADIAL ARTERIAL LINE SITE. THINKING THE PATIENT PULLED OUT HIS ARTERIAL LINE, THE NURSE HELD PRESSURE AT THE SITE. WHILE ASSISTING THE NURSE I REALIZED THAT THE PATIENT HAD NOT PULLED HIS ARTERIAL LINE BUT THAT THE LINE THAT CONNECTED TO THE STOPCOCK HAD FALLEN OUT. THE LINE HAD NOT BEEN BROKEN OFF NOR WAS THE STOPCOCK CRACKED IT JUST SEPARATED FROM EACH OTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545560 SET, ADMINISTRATION, INTRAVASCULAR FPA EDWARD LIFESCIENCES LLC 60014182

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR