BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUBCLAVIAN CATHETER

    MDR report key: 26559 · Received September 8, 1995

    Report

    Report Number
    26559
    Event Type
    Malfunction
    Date Received
    September 8, 1995
    Date of Event
    July 25, 1995
    Report Date
    August 29, 1995
    Manufacturer
    NEOSTAR MEDICAL TECHNOLOGIES, INC.
    Product Code
    LFJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 7/25/95 PT WAS BEING PREPARED FOR HEMODIALYSIS TREATMENT. WHEN CATHETER WAS BEING FLUSHED WITH HEPARIN, VENOUS ADAPTER FELL OUT. PT LOST SMALL AMOUNT OF BLOOD. ADAPTER WAS REPLACED, APPEARED PATENT. BLOOD CULTURES WERE DRAWN & ANTIBODIES ADMINISTERED. ON 7/27/95 POST DIALYSIS DURING HEPARIN FLUSH, ADAPTER AGAIN FELL OUT OF VENOUS SIDE. CATHETER REMOVED BY PHYSICIAN & NOT USED AFTER THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUBCLAVIAN CATHETER Implant CATHETER LFJ NEOSTAR MEDICAL TECHNOLOGIES, INC. DLC600TECX AT106

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other JULY 1,4,6,8,11,13,15,18,20,22,25,27| JUNE 17,20,22,24,27,29