BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALYSIS UNKNOWN

    MDR report key: 3823080 · Received April 30, 2014

    Report

    Report Number
    1317749-2014-00210
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    November 1, 2013
    Report Date
    April 15, 2014
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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)(4) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THE PALINDROME CATHETER WAS PLACED (B)(6) 2012. THE CATHETER HAD A LEAK NEAR THE Y JUNCTION. THIS WAS DISCOVERED AS THE STAFF WAS PREPPING THE PATIENT FOR DIALYSIS, AS THEY FLUSHED THE CATHETER WITH SALINE. THE CATHETER WAS PULLED AND REPLACED WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259530 DIALYSIS UNKNOWN PALINDROME CATHETER MSD COVIDIEN UNK DY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK