BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    36CM PERM CATH KIT X5

    MDR report key: 2123620 · Received June 10, 2011

    Report

    Report Number
    1317749-2011-00181
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 26, 2011
    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: 06/10/2011. 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 ADAPTER. DURING HEMODIALYSIS PROCEDURE, CHIEF NURSE FOUND THE CATHETER COULD NOT BE SEPARATED FROM THE HEPARIN CAP WITH REPEATED SCREWING. THE HEPARIN CAP WAS FINALLY DAMAGED BUT COULD NOT BE REMOVED FROM WITHIN THE CATHETER. THE CATHETER HAD TO BE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 36CM PERM CATH KIT X5 HEMODIALYSIS CATHETER LFJ COVIDIEN 8817748001 015518

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK