BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 3-LUMEN 7 FR X 20 CM

    MDR report key: 1040765 · Received May 9, 2008

    Report

    Report Number
    1036844-2008-00073
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 24, 2008
    Report Date
    May 9, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQO
    PMA / PMN Number
    K993691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT THE PROCEDURE WAS BEING PERFORMED ON A PT IN THE EMERGENCY DEPARTMENT. DUE TO PRIOR BURNS/SCARS ON PATIENTS NECK, THE FEMORAL SITE WAS USED FOR CENTRAL VENOUS CATHETER PLACEMENT. MD REPORTED DURING PLACEMENT, INTRODUCER NEEDLE WAS INSERTED & SPRING WIRE GUIDE (SWG) WAS PLACED. THE TISSUE DILATOR WAS INSERTED & CATHETER WAS PLACED OVER SWG. ONCE CATHETER WAS IN DESIRED LOCATION MD ATTEMPTED TO REMOVE SWG. SWG CAME OUT 5CM & STOPPED. HE TUGGED, PULLED, & PUSHED ON SWG, WITH LITTLE FORCE BEING USED & IT UNRAVELED. MD PULLED UNTIL ENTIRE SWG WAS OUT OF PATIENTS BODY. HE WAS SATISFIED ENTIRE SWG WAS REMOVED & NO FURTHER TESTING WAS ORDERED. THERE WAS NO PT INJURY & PT WAS DISCHARGED IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 3-LUMEN 7 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS DQO ARROW INTL., INC. RF8020088

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR