BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4 FR POWERWAND MIDLINE CATHETER

    MDR report key: 8699908 · Received June 13, 2019

    Report

    Report Number
    MW5087362
    Event Type
    Injury
    Date Received
    June 13, 2019
    Date of Event
    June 5, 2019
    Report Date
    June 11, 2019
    Manufacturer
    ACCESS SCIENTIFIC, LLC
    Product Code
    OWL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MEDLINE CATHETERIZE 4 FR POWERWAND, WAS INSERTED IN THE RIGHT CEPHALIC VEIN, INSERTED THE CATHETER, CONNECTED THE TUBING AND ADDED ADHESIVE TO THE PUNCTURE SITE. AREA WAS ALLOWED TO DRY AND THE VASCULAR ASSESS RN STARTED TO APPLY THE TEGADERM CHG GEL ADHESIVE DRESSING. THE RN NOTICED BLOOD POOLING AT THE HUB LUERLOCK JUNCTION. PRESSURE HELD TO SITE. FLUSHED X2 WITH SALINE WHICH WAS NOTED TO COME OUT OF THE HUB LUER/LOCK JUNCTION SUSPECTING A LEAK. THE RN VERIFIED JUNCTION WAS SECURE. CATHETER REMOVED OVER GUIDEWIRE AND NEW CATHETER 4 FR POWERWAND INSERTED. NO LEAKING NOTED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490462 4 FR POWERWAND MIDLINE CATHETER PERIPHERAL CATHETER INSERTION KIT OWL ACCESS SCIENTIFIC, LLC 94103

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention