BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DY

    MDR report key: 2231076 · Received July 20, 2011

    Report

    Report Number
    1317749-2011-00218
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ARGYLE (SHERIDAN)
    Product Code
    FJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2011 THAT A CUSTOMER HAD AN ISSUE WITH A HEMODIALYSIS CATHETER. THE CUSTOMER REPORTS THE CLAMPS ON THE PALINDROME CATHETERS DO NOT OPEN UP ALL THE WAY, CREATING A KINK IN THE CATHETER THAT DECREASES THE BLOOD FLOW. FOR ONE PATIENT, THE CATHETER HAD TO BE REMOVED AND REPLACED DUE TO DECREASED FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DY HEMODIALYSIS CATHETER FJS ARGYLE (SHERIDAN) UNKNOWN DY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK