BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2017 NAVICATH KIT

    MDR report key: 6490750 · Received April 13, 2017

    Report

    Report Number
    1062474-2017-00004
    Event Type
    Malfunction
    Date Received
    April 13, 2017
    Report Date
    February 9, 2017
    Manufacturer
    MYELOTEC, INC
    Product Code
    HRX
    PMA / PMN Number
    K980734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROCESS.

    Description of Event or Problem · 1

    INTRODUCER PROVIDED BROKE OFF DURING EXTRACTION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273733 2017 NAVICATH KIT CATHETER WITH COMPONENTS HRX MYELOTEC, INC 5158/MY28416

    Patients

    Seq Age Sex Outcome Treatment
    1