BEUDAMED
    FDA Adverse Event Injury Summary report: N

    14F X 28CM SPLIT STREAM

    MDR report key: 3896265 · Received June 16, 2014

    Report

    Report Number
    2518902-2014-00040
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 9, 2014
    Report Date
    June 10, 2014
    Manufacturer
    MEDCOMP
    Product Code
    FJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PERFORATION IS A KNOWN POTENTIAL COMPLICATION OF ANY CENTRAL VENOUS CATHETER INSERTION.

    Description of Event or Problem · 1

    DURING CATHETER INSERTION, WHERE THE SHEATH DILATOR INSERTED BECAME A BLOOD VESSEL PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353463 14F X 28CM SPLIT STREAM HEMODIALYSIS CATHETER FJS MEDCOMP SST28-J MBQA860

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention