BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILYST MEDICAL

    MDR report key: 1250732 · Received December 1, 2008

    Report

    Report Number
    1317056-2008-00097
    Event Type
    Malfunction
    Date Received
    December 1, 2008
    Date of Event
    November 3, 2008
    Report Date
    November 3, 2008
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH NO USED DEVICES ARE BEING RETURNED FOR ANALYSIS, AN INVESTIGATION IS BEING CONDUCTED INTO THIS REPORTED EVENT. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. (B) (4).

    Description of Event or Problem · 1

    AS REPORTED BY HOSPITAL, THE NEW 5F PEELABLE SHEATH "IS LARGER AND IS CAUSING MORE BLEEDING, DIFFICULT TO INSERT, PAINFUL FOR PATIENTS". NAVILYST MEDICAL RECENTLY CHANGED SUPPLIERS FOR THIS DEVICE. NO USED DEVICES ARE BEING RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVILYST MEDICAL PEELABLE SHEATH INTRODUCER LJS NAVILYST MEDICAL NA 1286088

    Patients

    Seq Age Sex Outcome Treatment
    1