BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX-NECK ARC PERITONEAL DIALYSIS CATH

    MDR report key: 3853583 · Received April 3, 2014

    Report

    Report Number
    1721504-2014-00074
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 12, 2014
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    FJS
    PMA / PMN Number
    K070730
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: NO DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IMPLANT DATE WAS AN ESTIMATE, EXACT DAY OF IMPLANTATION IN MAY 2012 WAS NOT PROVIDED. SINCE THE LOT NUMBER WAS NOT PROVIDED, THE DEVICE HISTORY RECORD AND COMPLAINT DATABASE SEARCH COULD NOT BE PERFORMED. MERIT IS UNABLE TO DETERMINE A ROOT CAUSE WITHOUT THE ACTUAL DEVICE.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE LUER CONNECTOR SEPARATED FROM THE CATHETER. THE DEVICE WAS REPAIRED AT A CLINIC WITHOUT FURTHER INCIDENT. NO LOT NUMBER HAS BEEN PROVIDED. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201761 FLEX-NECK ARC PERITONEAL DIALYSIS CATH CATHETER, PERITONEAL, LONG-TERM FJS MERIT MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1