BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOUR-WAY STOPCOCK

    MDR report key: 3092159 · Received April 29, 2013

    Report

    Report Number
    MW5030016
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 29, 2013
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FMG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IV TUBING WAS FOUND TO BE IN TWO SECTIONS AT THE STOP-COCK JUNCTION. THIS IS NORMALLY A PERMANENTLY ATTACHED TUBING TO STOP-COCK JUNCTION. WHEN NOTED, PT WAS LYING ON TUBING. THE TUBING WAS SEPARATED FROM THE STOP-COCK. THE IV WAS OPEN TO AIR. IT APPEARED THAT TUBING HAD PULLED APART FROM STOP-COCK. PT DEVELOPED PHLEBITIS ON ARM EXTENDING FROM SITE OF IV INSERTION TO AXILLA. REQUIRED IV ANTIBIOTIC THERAPY FOR 6 DOSES AND EXTENDED LENGTH OF STAY IN ACUTE CARE FOR 2 DAYS TO RECEIVE THERAPY AND MONITOR RESPONSE. PT DC'D HOME ON ORAL ANTIBIOTICS FOR ADD'L 5 DAYS OF THERAPY. TUBING OPENED AND BEGAN USING ON DAY OF SURGERY - (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184360 FOUR-WAY STOPCOCK FOUR-WAY STOPCOCK FMG SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization