BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDINAL HEALTH

    MDR report key: 860574 · Received May 23, 2007

    Report

    Report Number
    860574
    Event Type
    Injury
    Date Received
    May 23, 2007
    Date of Event
    April 9, 2007
    Report Date
    May 22, 2007
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KDQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THORACENTESIS PERFORMED. CATHETER SHEARED OFF, AS IT WAS PULLED BACK INTO THE NEEDLE AND CATHETER TIP RETAINED IN RIGHT PLURAL SPACE. PHYSICIANS STATED THEY WERE UNABLE TO DETERMINE IF THE CATHETER WAS INTACT UPON REMOVAL, DUE TO THE CATHETER BEING INSIDE THE NEEDLE AND ENCLOSED IN OPAQUE COVERING. PT TAKEN FOR SURGERY IN 2007. PHYSICIANS STATE, PT REQUIRED SURGERY FOR TB REGARDLESS OF THE RETAINED CATHETER, NO DAMAGE FROM CATHETER NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDINAL HEALTH THORACENTESIS CATHETER KDQ CARDINAL HEALTH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention THORACENTESIS WITH ARROW CATHETER