BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT 11.5FX19.5CM MAHURKAR

    MDR report key: 2512632 · Received March 28, 2012

    Report

    Report Number
    1317749-2012-00076
    Event Type
    Malfunction
    Date Received
    March 28, 2012
    Report Date
    March 4, 2012
    Manufacturer
    COVIDIEN
    Product Code
    LFJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(6) 2012. 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 REPORTS A FEMALE PATIENT (B)(6) HAS CATHETER IN PLACE THAT IS BROKEN AND OCCLUDED. THE CATHETER WAS PULLED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIT 11.5FX19.5CM MAHURKAR DIALYSIS CATHETER LFJ COVIDIEN 8813793009 118120X

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR