BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX-NECK ARC PERITONEAL DIALYSIS CATH

    MDR report key: 3810783 · Received March 21, 2014

    Report

    Report Number
    1721504-2014-00067
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    February 25, 2014
    Report Date
    February 26, 2014
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    FJS
    PMA / PMN Number
    K070730
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE USED DEVICE WAS RETURNED FOR EVALUATION. EXPLANT DATE IS AN ESTIMATE. SINCE THE LOT NUMBER WAS NOT PROVIDED, THE DEVICE HISTORY RECORD AND COMPLAINT DATABASE COULD NOT BE REVIEWED. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT POST PLACEMENT, THE CATHETER WOULD NOT FLUSH OR DRAIN PROPERLY. THE DEVICE WAS EXCHANGED. THE CATHETER WAS LOOPED IN THE PATIENT'S BELLY AFTER IT WAS REMOVED, AND WAS FOUND TO HAVE FIBRIN CLOGGING THE LUMEN. THE PHYSICIAN PLACES THE DEVICE UTILIZING AN OPEN PROCEDURE RATHER THAN LAPAROSCOPICALLY. NO LOT NUMBER HAS BEEN PROVIDED. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169698 FLEX-NECK ARC PERITONEAL DIALYSIS CATH CATH, PERITONEAL, LONG-TERM FJS MERIT MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1