BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXZERO NEEDLELESS CONNECTOR

    MDR report key: 4866335 · Received June 24, 2015

    Report

    Report Number
    9616066-2015-00746
    Event Type
    Injury
    Date Received
    June 24, 2015
    Date of Event
    May 7, 2015
    Report Date
    May 28, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K132413
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION INITIAL REPORTER ADDRESS.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED PER CUSTOMER. NO INVESTIGATION WAS PERFORMED. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    RECEIVED FROM THE FDA A COPY OF THE CUSTOMER'S MEDWATCH WHICH STATES: "INFANT HAD MEDLINE TUBING CONNECTED TO BROVIAC. NEEDLELESS CONNECTOR FOUND DISCONNECTED FROM THE MEDLINE AND SYRINGE. THERE WAS APPROXIMATELY 44 MLS OF BLOOD AND INTRAVASCULAR FLUID ON THE FLOOR. MEDICAL INTERVENTION WAS REQUIRED." THE CUSTOMER FURTHER CLARIFIED THAT THE BABY LOST 30 ML/KG OF BLOOD, REQUIRED A TRANSFUSION, AND WAS MORE STABLE AFTER THAT RELATIVE TO THE FLUID LEAK. THE SYRINGE MALE LUER TIP DISCONNECTED FROM THE FEMALE LUER OF THE VALVE AND THE MALE LUER OF THE VALVE ALSO DISCONNECTED FROM THE FEMALE LUER OF THE EXTENSION SET IT WAS CONNECTED TO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408416 MAXZERO NEEDLELESS CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION MZ1000-07 15038068

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Required Intervention