BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    36CM PERM CATH KIT X5

    MDR report key: 1921997 · Received December 7, 2010

    Report

    Report Number
    1317749-2010-00324
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    November 13, 2010
    Report Date
    December 2, 2010
    Manufacturer
    COVIDIEN
    Product Code
    LFJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2010. 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) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A HEMODIALYSIS CATHETER. THE CUSTOMER STATED THE SURGEON COULD NOT TAKE OFF THE CONNECTOR (ADAPTER) OF THE CATHETER TUBING AND DIALYSIS TUBING DURING PROCEDURE; HE THEN CHANGED TO A NEW DIALYSIS CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 36CM PERM CATH KIT X5 HEMODIALYSIS CATHETER LFJ COVIDIEN 8817748001 007126

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK