BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILYST MEDICAL /XCELA

    MDR report key: 3002584 · Received February 13, 2013

    Report

    Report Number
    1317056-2013-00004
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    LJS
    PMA / PMN Number
    K091261
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USED SHEATH DEVICE HAS BEEN RETURNED TO NAVILYST MEDICAL AND WAS FORWARDED TO OUR SUPPLIER, (B)(4). FOR EVAL AND COMPLETION OF A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR). UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED, THE HANDLES OF THE 5F PEEL-AWAY SHEATH PACKAGED WITH THE NAVILYST MEDICAL PICC BROKE OFF WHEN THE NURSE WAS TRYING TO PEEL DURING INSERTION. THE SHEATH WAS ABLE TO BE EASILY GRASPED AND REMOVED, WITH NO PATIENT INJURY OR COMPLICATIONS. THE USED DEVICE HAS BEEN RETURNED TO NAVILYST MEDICAL FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63947 NAVILYST MEDICAL /XCELA CATHETER, INTRAVASCULAR, THERAPEUTIC LJS NAVILYST MEDICAL NA 4506984

    Patients

    Seq Age Sex Outcome Treatment
    1