BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALIND 28/45 SLOT KIT W/VT

    MDR report key: 2941720 · Received January 2, 2013

    Report

    Report Number
    1317749-2013-00002
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    November 24, 2012
    Report Date
    December 5, 2012
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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)(4) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER REPORTED THE DEVICE WAS INSERTED ON (B)(6) 2012 AND THE LINE FELL OUT ON (B)(6) 2012. THE CATHETER MOVED OUT 4 INCHES AFTER 3 HRS, 55 MINS OF DIALYSIS. THIS INCIDENT HAPPENED AT A SATELLITE UNIT AND BY THE TIME THE PATIENT ARRIVED IN THE HOSPITAL EMERGENCY ROOM, THE CATHETER WAS NO LONGER IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1442 PALIND 28/45 SLOT KIT W/VT DIALYSIS CATHETER MSD COVIDIEN 8888145041 032235

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK