BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERMACATH, 36 CM

    MDR report key: 14617 · Received March 29, 1994

    Report

    Report Number
    14617
    Event Type
    Death
    Date Received
    March 29, 1994
    Date of Event
    June 29, 1993
    Report Date
    February 28, 1994
    Manufacturer
    QUINTON INSTRUMENT CO.
    Product Code
    LFJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD CATHETER IMPLANTED 6/28/93. PT HAD AN ATTEMPTED INSERTION AT BEDSIDE. UNABLE TO COMPLETE THIS ATTEMPT. PT TAKEN TO OR FOR INSERTION. PT WENT TO DIALYSIS 6/28/93, FROM 11 AM TO 2:15 PM. PT HAD SERIOUS DRAINAGE ON DRESSING AND WAS MONITORED FOR THIS. PT WAS EDEMATOUS. ON 6/29/93, AT 4 PM PT WAS RESTLESS AND DRESSING WAS REINFORCED AT INSERTION SITE. CLAMPS AND CAPS WERE PRESENT AND INTACT. AT APPROX 4:45 AM, PT WAS FOUND WITH DRESSING OFF, CATHETER IN PLACE, CAP MISSING, BLOOD ON FLOOR. PT WAS UNABLE TO BE REVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMACATH, 36 CM Implant CATHETER LFJ QUINTON INSTRUMENT CO. 060347 (9/92)

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death