BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME 23/40 KIT W/SLOT

    MDR report key: 3851349 · Received March 26, 2014

    Report

    Report Number
    1317749-2014-00167
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 13, 2014
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    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) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THAT THERE WAS A LEAK AT THE Y-JUNCTION. THE CATHETER REMAINED IN THE PATIENT DURING 11 MONTHS, 23 DAYS. ON (B)(6) 2014, THE CATHETER WAS PULLED AND REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176639 PALINDROME 23/40 KIT W/SLOT DIALYSIS CATHETER MSD COVIDIEN 8888145015 118021

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK