BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK DY

    MDR report key: 3770304 · Received March 7, 2014

    Report

    Report Number
    1317749-2014-00152
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    December 27, 2013
    Report Date
    February 25, 2014
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    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 THE PT WAS SENT TO (B)(6) FOR CATHETER REPAIR DUE TO CRACKING OF AN ADAPTER. INSTEAD OF USING A REPAIR KIT, THEY REPLACED THE PALINDROME CATHETER WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139568 UNK DY PALINDROME CATHETER MSD COVIDIEN UNK DY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK