BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME SAPPHIRE 28/45SP VT

    MDR report key: 1379570 · Received March 9, 2009

    Report

    Report Number
    1317749-2009-00051
    Event Type
    Malfunction
    Date Received
    March 9, 2009
    Date of Event
    February 12, 2009
    Report Date
    February 27, 2009
    Manufacturer
    COVIDIEN
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 03/05/2009. AN INVESTIGATION IS CURRENTLY UNDERWAY; UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN IN 2009 THAT A CUSTOMER HAD AN ISSUE WITH A HEMODIALYSIS CATHETER. THE CUSTOMER REPORTS THE CATHETER FELL OUT OF THE PT. WHEN DIALYSIS STAFF WENT TO DIALYZE, THEY COULD NOT FIND THE CATHETER; WHEN THEY WERE UNDRESSING HIM FOR THE PROCEDURE TO REPLACE THE CATHETER, THE OLD CATHETER WAS FOUND IN HIS SHIRT SLEEVE. THIS WAS A LIJ 28 CM CATHETER, WHICH WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALINDROME SAPPHIRE 28/45SP VT HEMODIALYSIS CATHETER MPB COVIDIEN 888128459 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK