BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL CAVH CATHETER

    MDR report key: 221335 · Received April 29, 1999

    Report

    Report Number
    2518902-1999-00050
    Event Type
    Injury
    Date Received
    April 29, 1999
    Date of Event
    March 25, 1999
    Report Date
    April 5, 1999
    Manufacturer
    MEDCOMP
    Product Code
    LFK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE RISK MGR REPORTED THAT THE CATHETER WAS INSERTED INTO THE RIGHT FEMORAL ARTERY. THE CATHETER WAS CRACKED, WHICH INDUCED BLEEDING. THE PT LOST APPROX 400CC OF BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL CAVH CATHETER Implant ARTERIAL CAVH CATHETER LFK MEDCOMP NA M816540

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R