BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DY

    MDR report key: 2231085 · Received July 20, 2011

    Report

    Report Number
    1317749-2011-00219
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 12, 2011
    Manufacturer
    COVIDIEN
    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 ALL THE WAY, CREATING A KINK IN THE TUBING THAT IMPEDES BLOOD FLOW. A PATIENT HAD HIS CATHETER REMOVED AND REPLACED DUE TO POOR FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DY HEMODIALYSIS CATHETER FJS COVIDIEN UNKNOWN DY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK