BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBCLAVIAN CATHETER IJ

    MDR report key: 510303 · Received February 9, 2004

    Report

    Report Number
    2518902-2003-00160
    Event Type
    Injury
    Date Received
    February 9, 2004
    Date of Event
    November 3, 2003
    Report Date
    November 4, 2003
    Manufacturer
    MEDCOMP
    Product Code
    LFJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A TOTAL OF 13 DIALYSIS TREATMENTS THE CATHETER HUB WAS BROKEN. NO BLOOD LOSS OR PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUBCLAVIAN CATHETER IJ HEMODIALYSIS CATHETER LFJ MEDCOMP NA M337880

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention