BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX-NECK ARC PERITONEAL DIALYSIS CATH

    MDR report key: 3832072 · Received March 7, 2014

    Report

    Report Number
    1721504-2014-00042
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    March 1, 2014
    Report Date
    February 6, 2014
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    FJS
    PMA / PMN Number
    K070730
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: NO DEVICE IS EXPECTED TO BE RETURNED FOR EVAL. IMPLANT DATE WAS AN ESTIMATE, EXACT DAY OF IMPLANTATION IN NOVEMBER 2011 WAS NOT PROVIDED. SINCE THE LOT NUMBER WAS NOT PROVIDED, THE DEVICE HISTORY RECORD AND COMPLAINT DATABASE SEARCH COULD NOT BE PERFORMED. A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE CATHETER LUER DISCONNECTED FROM THE CATHETER. THE DEVICE WAS REPAIRED AT A CLINIC W/O FURTHER INCIDENT. NO LOT NUMBER HAS BEEN PROVIDED. DATE OF EVENT IS AN ESTIMATE, EXACT DAY IN MARCH WAS NOT PROVIDED. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138603 FLEX-NECK ARC PERITONEAL DIALYSIS CATH CATHETER, PERITONEAL, LONG-TERM FJS MERIT MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1