BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEX-NECK ARC PERITONEAL DIALYSIS CATH

    MDR report key: 4240326 · Received October 30, 2014

    Report

    Report Number
    1721504-2014-00261
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 2, 2014
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    FJS
    PMA / PMN Number
    K070730
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: NO DEVICE IS EXPECTED TO BE RETURNED FOR EVAL. SINCE THE LOT NUMBER WAS NOT PROVIDED, THE DEVICE HISTORY RECORD AND COMPLAINT DATABASE COULD NOT BE REVIEWED. BECAUSE THE UNIT WAS NOT RETURNED, THE ROOT CAUSE COULD NOT BE DETERMINED. IF THE DEVICE IS RETURNED IN THE FUTURE, THIS INVESTIGATION WILL BE REOPENED AND A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE CATHETER LUER SEPARATED FROM THE CATHETER. THE DEVICE WAS REPAIRED AND IS STILL BEING USED BY THE PT. NO LOT NUMBER HAS BEEN PROVIDED. NO IMPLANT OR EXPLANT DATE WAS PROVIDED. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694875 FLEX-NECK ARC PERITONEAL DIALYSIS CATH CATHETER, PERITONEAL, LONG-TERM FJS MERIT MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1