BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    14.5FX24CM HEMO-FLOW DBL LMN

    MDR report key: 1702168 · Received May 21, 2010

    Report

    Report Number
    2518902-2010-00034
    Event Type
    Malfunction
    Date Received
    May 21, 2010
    Date of Event
    June 15, 2009
    Report Date
    May 18, 2010
    Manufacturer
    MEDCOMP
    Product Code
    LFJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE CATHETER REVEALED A CRACK ON THE SIDE OF THE HUB OF THE CATHETER BY THE SUTURE WING THAT LEAKED WHEN THE DEVICE WAS FLUSHED. WITHOUT THE LOT NUMBER, WE WERE UNABLE TO REVIEW THE MANUFACTURING RECORDS. THE INCIDENT REPORT NOTED THAT THE CATHETER FUNCTIONED WITHOUT A PROBLEM FOR 90 DAYS. WE ARE UNABLE TO DETERMINE THE CAUSE OR FACTORS WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THIS IS THE FIRST REPORTED INCIDENT OF THIS NATURE FOR THIS PRODUCT FAMILY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS LEAKAGE FROM THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 14.5FX24CM HEMO-FLOW DBL LMN HEMODIALYSIS CATHETER LFJ MEDCOMP HFS24E. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR