BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    36CM PERM CATH KIT X5

    MDR report key: 2914171 · Received December 7, 2012

    Report

    Report Number
    1317749-2012-00316
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 10, 2012
    Report Date
    November 12, 2012
    Manufacturer
    COVIDIEN
    Product Code
    LFJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED. (B)(4).

    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. DURING DIALYSIS THE AIR-ALARM OF THE MACHINE SOUNDED AND CRACKS WERE FOUND ON THE CONNECTING POINT OF THE RED ADAPTER. 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 DIALYSIS CATHETER LFJ COVIDIEN 8817748001 023814

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK