BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALIND 28/45 SLOT KIT W/VT

    MDR report key: 2914169 · Received December 7, 2012

    Report

    Report Number
    1317749-2012-00319
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    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)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THAT THE DOCTOR PLACED THE PALINDROME CATHETER IN HIS PT AND THE PT COMPLAINED OF THE HUB CRACKING AND SMALL AMOUNT OF BLOOD LEAKING OUT. DR. (B)(6) REMOVED THE PALINDROME TO PROVIDE THE SAMPLE TO US BUT TRIED TO FIX THE HUB WITH SOME KIND OF GLUE/BOND, WHICH DID NOT WORK. DR. (B)(6) REMOVED THE PALINDROME AND REPLACED IT WITH ANOTHER CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALIND 28/45 SLOT KIT W/VT DIALYSIS CATHETER MSD COVIDIEN 8888145041 126659X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK