BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLAVE SYSTEM W/ REMOVABLE CAP

    MDR report key: 745630 · Received June 15, 2006

    Report

    Report Number
    MW1039650
    Event Type
    Other
    Date Received
    June 15, 2006
    Date of Event
    May 13, 2006
    Report Date
    May 26, 2006
    Manufacturer
    HOSPIRA WORLDWIDE INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 05/13/2006, THE RN WENT TO FLUSH THE CATHETER, AND SHE NOTED LEAKAGE OF THE NS. THE "PIGTAIL" FELL APART IN HER HAND. SHE WAS UNABLE TO REMOVE THE PIECE LEFT IN THE IV CATHETER. SHE REMOVED THE IV LINE, AND REINSERTED A NEW IV LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLAVE SYSTEM W/ REMOVABLE CAP MICROBORE EXTENSION SET 8 INCH FPA HOSPIRA WORLDWIDE INC * 39156NS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other