BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMCATH DUAL LUMEN

    MDR report key: 33731 · Received May 31, 1996

    Report

    Report Number
    33731
    Event Type
    Malfunction
    Date Received
    May 31, 1996
    Date of Event
    April 23, 1996
    Report Date
    May 1, 1996
    Manufacturer
    QUINTON INSTRUMENT CO.
    Product Code
    LFJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CATHETER WAS EXPLANTED (DUE TO POOR FUNCTION) AND REPLACED. CATHETER INADEQUATE FOR DIALYSIS. TWO ER VISITS FOR DECLOTTING ARTERIAL CHANNEL. POOR AND INTERMITTENT FLOW PATTERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMCATH DUAL LUMEN Implant CATHETER LFJ QUINTON INSTRUMENT CO. 36CM 873386-1

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR