BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-Z COIL SPECIAL (OZ C CA2)

    MDR report key: 3788163 · Received January 13, 2014

    Report

    Report Number
    1317749-2014-00018
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    December 20, 2013
    Report Date
    December 20, 2013
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    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) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THAT THE CATHETER WAS IMPLANTED IN 2008 IN A PT. DUE TO STRUCTURAL CHANGED OF THE CATHETER MATERIAL IT HAS BEEN DECIDED TO REMOVE THE CATHETER ON (B)(6) 2013. NO PT INJURY HAS BEN REPORTED AND NO PROPHYLACTIC ANTIBIOTIC TREATMENT WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33462 O-Z COIL SPECIAL (OZ C CA2) DIALYSIS CATHETER MSD COVIDIEN 8888425710 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK