BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME 23/40 KIT W/ SLOT

    MDR report key: 1952674 · Received January 4, 2011

    Report

    Report Number
    1317749-2011-00002
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 17, 2010
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2011. 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) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A HEMODIALYSIS CATHETER. THE CUSTOMER REPORTS THAT THE CATHETER WAS INSERTED (B)(6) 2010 AND IT WAS NOTICED ON (B)(6) 2010 THAT THERE WAS A LEAK ON THE BLUE SILICONE EXTENSION (VENOUS SIDE) BLUE CONNECTOR. THE CATHETER WAS CHANGED THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALINDROME 23/40 KIT W/ SLOT HEMODIALYSIS CATHETER MSD COVIDIEN 8888145015 020323

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK