BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOCARE

    MDR report key: 5409845 · Received March 4, 2005

    Report

    Report Number
    1649393-2005-00011
    Event Type
    Injury
    Date Received
    March 4, 2005
    Report Date
    February 25, 2015
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    2

    Narratives

    Additional Manufacturer Narrative · 1

    RECOMMENDATIONS WERE MADE BY CO. REPRESENTATIVES TO INVOLVED CLINICIANS. THERE WAS FOLLOW UP RECORDED THAT INDICATES INCIDENCE OF PHLEBITIS DECREASED AFTER FOLLOWING RECOMMENDATIONS MADE. THERE IS NO INFORMATION CONTAINED IN FILE THAT SUGGESTS PROBLEM RESURFACED. AS EVENTS OCCURRED LAST YEAR, NO OTHER INFORMATION IS AVAILABLE SPECIFIC TO THIS REPORT.

    Description of Event or Problem · 1

    FACILITY REPORTS INCREASED INCIDENCE OF PHLEBITIS, ESPECIALLY WHEN LINE IS PLACED IN LEG. FROM (B)(6) 2003, 290 LINES WERE PLACED AND ZERO INSTANCES OF PHLEBITIS WERE REPORTED. FROM (B)(6) 2003 THRU (B)(6) 2004, 84 LINES WERE PLACED WITH 5 INSTANCES OF PHLEBITIS DOCUMENTED. ALL 5 WERE PLACED IN LEG. FOLLOW UP IN (B)(6) 2004 FOUND CUSTOMER REPORTING A DECREASE IN PHLEBITIS. NO ADVERSE SEQUELAE IS REPORTED. NO OTHER DETAILS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOCARE SILICONE PERIPHERALLY INSERTED CATHETER DYB ARROW INTL., INC. S1PIC 1.9-S VARIOUS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other