BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME SAPPHIRE 23/40KT VT

    MDR report key: 3060064 · Received March 20, 2013

    Report

    Report Number
    1317749-2013-00099
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    March 13, 2013
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 THE ADAPTER BROKE. THE CATHETER WAS PULLED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114853 PALINDROME SAPPHIRE 23/40KT VT DIALYSIS CATHETER MSD COVIDIEN 8888145048 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK