BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXZERO NEEDLELESS CONNECTOR

    MDR report key: 4790305 · Received May 18, 2015

    Report

    Report Number
    4790305
    Event Type
    Injury
    Date Received
    May 18, 2015
    Date of Event
    May 7, 2015
    Report Date
    May 14, 2015
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INFANT HAD MEDLINE TUBING CONNECTED TO BROVIAC. NEEDLELESS CONNECTOR FOUND DISCONNECTED FROM THE MEDLINE AND SYRINGE. THERE WAS APPROXIMATELY 44MLS OF BLOOD AND INTRAVASCULAR FLUID ON THE FLOOR. MEDICAL INTERVENTION WAS REQUIRED.======================MANUFACTURER RESPONSE FOR NEEDLESS CONNECTOR, MAXZERO NEEDLESS CONNECTOR (PER SITE REPORTER).======================UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321454 MAXZERO NEEDLELESS CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 303, INC. * 15038068

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Required Intervention MAXZERO NEEDLESS CONNECTOR, MAXGUARD EXTENSION SET| (ULTRAMINIBORE) BD 10ML LEURLOCK NS SYRINGE.