BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER DUAL LUMEN

    MDR report key: 5285461 · Received December 4, 2015

    Report

    Report Number
    MW5058424
    Event Type
    Injury
    Date Received
    December 4, 2015
    Date of Event
    November 3, 2015
    Report Date
    December 4, 2015
    Manufacturer
    COVIDIEN L. L. C.
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) INFANT REQUIRED PLACEMENT OF AN UMBILICAL VESSEL CATHETER FOR SECURE IV ACCESS. WHEN THE NURSE ASPIRATED BLOOD FROM THE UNCAPPED PORT TO DRAW BLOOD CULTURES. BLOOD FLOWED BACK INTO BOTH LUMENS AND FILLED THE PORT. NURSE THOUGHT IT TO BE A HUB ISSUE, SO HUB WAS CHANGED OUT. THE NURSE THEN ASPIRATED BLOOD FROM THE UNCAPPED PORT AND AGAIN BLOOD FLOWED BACK INTO BOTH LUMENS. NURSE WITHDRAW THE CATHETER. AS A RESULT OF THE DEFECTIVE DEVICE, THERE WAS A TOTAL OF 3 ATTEMPTS TO SECURE AND UMBILICAL LINE ON THE INFANT. NO FURTHER ISSUES ONCE THE NEW UMBILICAL LINE WAS SECURED. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797109 ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER DUAL LUMEN ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER DUAL LUMEN FOS COVIDIEN L. L. C. 1416500010

    Patients

    Seq Age Sex Outcome Treatment
    1 10 DA Required Intervention