BEUDAMED
    FDA Adverse Event Summary report: N

    CENTRAL VENOUS POLYETHYLENE CATHETER

    MDR report key: 2160551 · Received July 6, 2011

    Report

    Report Number
    2160551
    Date Received
    July 6, 2011
    Date of Event
    January 25, 2011
    Report Date
    July 6, 2011
    Manufacturer
    COOK MEDICAL
    Product Code
    DRS
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AREA AROUND WRIST ARTERIAL LINE WAS INFILTRATED. RN ATTEMPTED TO STOP PRESSURE BAG OF HEPARINIZED SALINE AND DISCONTINUE THE LINE. SUTURES WERE CUT AND DRESSING WAS REMOVED. CATHETER SLIPPED OUT AND IT WAS NOTED THAT CATHETER WAS NIPPED WITH ONLY WHITE PLASTIC BASE LEFT. REMAINING CATHETER WAS RETAINED IN BODY AND REQUIRED SURGICAL REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRAL VENOUS POLYETHYLENE CATHETER ARTERIAL LINE-POLYETHYLENE CATHETERPRESSURE MONITORING SET DRS COOK MEDICAL G02854 2564336

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR OTHER