BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALIND 19/36 SLOT SPRT W/VT

    MDR report key: 3170832 · Received May 23, 2013

    Report

    Report Number
    1317749-2013-00164
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    April 17, 2013
    Report Date
    May 10, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    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) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THE CATHETER WAS PULLING OUT AND THE CUFF MAY HAVE BEEN SEEN. THE CATHETER DILATED BETWEEN THE CUFF AND THE HUB. THE CATHETER WAS PULLED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228255 PALIND 19/36 SLOT SPRT W/VT DIALYSIS CATHETER MSD COVIDIEN LP 8888119364 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK