BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUBCLAVIAN CATHETER

    MDR report key: 25965 · Received August 28, 1995

    Report

    Report Number
    25965
    Event Type
    Malfunction
    Date Received
    August 28, 1995
    Date of Event
    July 25, 1995
    Report Date
    August 23, 1995
    Manufacturer
    NEOSTAR MED 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

    PT WAS BEING PREPARED FOR DIALYSIS. INJECTION CAP WAS REMOVED, HEPARIN WAS BEING INSTILLED IN VENOUS & ARTERIAL PORTS TO CHECK PATENCY & INITIATE DIALYSIS. LUER LOCK ADAPTER FELL OUT OF VENOUS SIDE. PT LOST SMALL AMOUNT OF BLOOD. CONTAMINATION OF PT DID OCCUR-RESULTED IN POSITIVE BLOOD CULTURES. LUER LOCK REPLACED, APPEARED STABLE & INTACT ARTERIAL SIDE. ON 7/29 ADAPTER FELL OUT AGAIN. CATHETER PULLED BY PHYSICIAN 7/30/95.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other 7/1,4,6,8,11,13,15,18,20,22,25,27/95| 6/17/95, 6/22/95, 6/27/95, 6/20/95, 6/24/95, 6/29,