BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME 19/36 KIT W/SLOT

    MDR report key: 2307766 · Received September 23, 2011

    Report

    Report Number
    1317749-2011-00258
    Event Type
    Malfunction
    Date Received
    September 23, 2011
    Report Date
    September 19, 2011
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 09/23/2011. 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) 2011 THAT A CUSTOMER HAS AN ISSUE WITH A HEMODIALYSIS CATHETER ADAPTER. THE CUSTOMER REPORTS THAT THE ADAPTER WAS CRACKING. THE CATHETER NEEDED TO BE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALINDROME 19/36 KIT W/SLOT HEMODIALYSIS CATHETER MSD COVIDIEN 8888145014 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK