BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT 28CM PERMCATH

    MDR report key: 2439233 · Received January 26, 2012

    Report

    Report Number
    1317749-2012-00029
    Event Type
    Malfunction
    Date Received
    January 26, 2012
    Date of Event
    January 12, 2012
    Report Date
    January 16, 2012
    Manufacturer
    COVIDIEN
    Product Code
    LFJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THE HUB IS SWELLING WHEN THE BLOOD IS FLOWING THROUGH. THE CATHETER HAS BEEN IN USE FOR THREE MONTHS. THE CUSTOMER REPORTED THE CATHETER WAS PULLED AND REPLACED AND THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIT 28CM PERMCATH DIALYSIS CATHETER LFJ COVIDIEN 8834369001 835507

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK