BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 2-LUMEN 8FR X 11CM

    MDR report key: 1061120 · Received June 13, 2008

    Report

    Report Number
    1000563940-2008-00003
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 20, 2008
    Report Date
    June 13, 2008
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQO
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS EVENT INVOLVED A FEMALE PATIENT. THE CLINICIAN REPORTED, WHEN TRYING TO FEED THE CATHETER OVER THE SPRING WIRE GUIDE (SWG), THE SWG BECAME STUCK AT THE HUB. BOTH THE CATHETER AND THE SWG WERE REMOVED, AND HE TRIED AGAIN USING THE SAME CATHETER BUT A NEW SWG. AFTER A THIRD, UNSUCCESSFUL ATTEMPT, HE USED A MEDCOMP DIALYSIS CATHETER WITH SUCCESS. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 2-LUMEN 8FR X 11CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQO ARROW INTERNATIONAL INC HF6038500

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Required Intervention MEDCOMP DIALYSIS CATHETER