BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICU MEDICAL

    MDR report key: 9720444 · Received February 18, 2020

    Report

    Report Number
    9720444
    Event Type
    Malfunction
    Date Received
    February 18, 2020
    Date of Event
    January 30, 2020
    Report Date
    February 4, 2020
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FROM STAFF: PATIENT RECEIVING IV ANTIBIOTICS EVERY 4 HOURS. WHILE DISCONNECTING THE IV TUBING FROM THE PICC HUB, THE LUER LOCK TIP BROKE OFF INTO THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) CLAVE. MINIMAL PRESSURE USED AND SNAP OCCURRED AS SOON AS THE TUBING WAS LIFTED. PICC LINE WAS CLAMPED IMMEDIATELY AS BLOOD STARTED COMING FROM THE PICC SINCE THE CLAVE WAS LOCKED OPEN. CLAVE WAS CHANGED, AND NEW TUBING WAS HUNG. PER CONVERSATION WITH ANOTHER NURSE, THIS HAS HAPPENED TO HER IV TUBING AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184142 ICU MEDICAL SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL, INC. 4390860

    Patients

    Seq Age Sex Outcome Treatment
    1 15695 DA