BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK INCORPORATED

    MDR report key: 225519 · Received May 18, 1999

    Report

    Report Number
    225519
    Event Type
    Injury
    Date Received
    May 18, 1999
    Date of Event
    April 8, 1999
    Report Date
    April 21, 1999
    Manufacturer
    COOK, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RIGHT RADIAL ARTERIAL LINE PLACED IN 1999. LINE WAS POSITIONAL WHEN PT BECAME RESTLESS. DRESSING WAS SECURE AND SOFT WRIST RESTRAINTS IN PLACE. 1999 AT 0200, LINE FUNCTIONING WELL WITH BLOOD RETURN. AT 0300 UPPER ARM WAS BLANCHING AND MOTTLED. UNABLE TO DRAW FROM LINE. PHYSICIAN NOTIFIED AND AT 0400 AND 0500 THE BLANCHING IMPROVED AND BLOOD COULD BE DRAWN. AT 0600, BLANCHING INCREASED ON UPPER ARM AND FINGERS NOTED TO BE DUSKY. PHYSICIAN ASSESSED AND ORDERED TO REMOVE THE LINE. DRESSING REMOVED, PT RESTLESS. UPON REMOVAL PER STANDARD TECHNIQUE IT WAS NOTED THAT THE HUB AND CATHETER WERE NOT INTACT, WITH THE CATHETER REMAINING IN THE PT. A CUT-DOWN WAS REQUIRED TO RETRIEVE THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK INCORPORATED Implant ARTERIAL CATHETER FOZ COOK, INC. C-PMS-250-RA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention