BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YOU-BEND TWO LUMEN HEMODIALYSIS CATHETERIZATION KIT

    MDR report key: 1802831 · Received August 10, 2010

    Report

    Report Number
    MW5017069
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 8, 2010
    Report Date
    August 10, 2010
    Manufacturer
    TELEFLEX
    Product Code
    LFJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MD WAS PLACING THE TEMPORARY DIALYSIS CATHETER. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE NEEDLE HUB. THE PLASTIC PART FELL APART FROM THE METAL PART OF THE NEEDLE. NEEDLE WAS REMOVED INTACT. NO INJURY OR ADDITIONAL INTERVENTION WAS REQUIRED TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 YOU-BEND TWO LUMEN HEMODIALYSIS CATHETERIZATION KIT HEMODIALYSIS CATHETER KIT LFJ TELEFLEX RF0046509

    Patients

    Seq Age Sex Outcome Treatment
    1