BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGUIDE CHRONIC DIALYSIS CATHETER

    MDR report key: 3241095 · Received July 18, 2013

    Report

    Report Number
    1721504-2013-00157
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    MSD
    PMA / PMN Number
    K042016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE CATHETER LEAKED FROM THE BLUE CONNECTOR. NO FURTHER INFO WAS PROVIDED. IMPLANTATION AND EXPLANTATION DATES FOR THE CATHETER WERE NOT PROVIDED. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335326 PROGUIDE CHRONIC DIALYSIS CATHETER CATHETER, HEMODIALYSIS, IMPLANTED MSD MERIT MEDICAL SYSTEMS, INC. H417866

    Patients

    Seq Age Sex Outcome Treatment
    1