BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRAL LINE CATHETER

    MDR report key: 3870210 · Received June 6, 2014

    Report

    Report Number
    MW5036538
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 5, 2014
    Manufacturer
    EDWARDS LIFE SCIENCES
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    (B)(6) 2014 EDWARDS TRIPLE LUMEN CENTRAL LINE IDENTIFIED AS NOT PROVIDING BLOOD RETURN EASILY, REQUIRED MULTIPLE FLUSHES BEFORE GIVING BLOOD. PATIENT COMPLAINT OF PAIN AT SITE WITH POTASSIUM INFUSION. CENTRAL LINE REMOVED AND FOUND TO HAVE A CRACK IN THE BLACK TUBING BETWEEN THE PHALANGES. QUALITY REVIEW IDENTIFIED CRACK IN THE "WHITE" CONNECTOR TO THE GREEN "Y" CONNECTOR. PATIENT HAD SWELLING AT THE SITE OF THE CENTRAL LINE THAT RESOLVED. DATES OF USE: (B)(6) 2014. DIAGNOSIS OR REASON FOR USE: FLUID REPLACEMENT, ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331478 CENTRAL LINE CATHETER TRIPLE LUMEN CATHETER LJS EDWARDS LIFE SCIENCES XA3820HKCDC 59628316

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention