BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.5FX20CM TPL LMN CATH

    MDR report key: 3938140 · Received March 12, 2014

    Report

    Report Number
    2518902-2014-00013
    Event Type
    Malfunction
    Date Received
    March 12, 2014
    Date of Event
    January 20, 2014
    Report Date
    March 11, 2014
    Manufacturer
    MEDCOMP
    Product Code
    MSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT OF A CENTRAL CATHETER BECOMING DETACHED FROM THE HUB AND COMING OUT OF THE PT DURING TREATMENT. NO HARM TO PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147297 11.5FX20CM TPL LMN CATH HEMODIALYSIS CATHETER MSD MEDCOMP XTP3118MTB MBLP290

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention