BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALYSIS UNK

    MDR report key: 3003647 · Received February 12, 2013

    Report

    Report Number
    1317749-2013-00075
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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)(4) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER REPORTS A MALE PT HAS PRESENTED TO OUR DIALYSIS UNIT WITH A BREAK IN HIS PALINDROME (HSI) CATHETER. THE CATHETER HAS BEEN IN USE FOR LESS THAN ONE YEAR. THE CRACK IS LOCATED AT THE HUB AREA. THE CATHETER WILL BE PULLED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61977 DIALYSIS UNK DIALYSIS CATHETER MSD COVIDIEN UNK DIALYSIS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK