BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME HSI KIT 23/40 CM X5.

    MDR report key: 3180202 · Received June 4, 2013

    Report

    Report Number
    1317749-2013-00170
    Event Type
    Malfunction
    Date Received
    June 4, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 27, 2013
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2013. 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) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATED THEY NOTICED AIR UPON CONNECTING TO MACHINE AND AFTER EXAMINATION THERE IS A BREAK AROUND THE HUB AREA. THE CATHETER WILL BE REMOVED AND A NEW CATHETER WILL BE INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247802 PALINDROME HSI KIT 23/40 CM X5. DIALYSIS CATHETER MSD COVIDIEN 8888145048C UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK