BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROCLAVE

    MDR report key: 9601437 · Received January 17, 2020

    Report

    Report Number
    9601437
    Event Type
    Malfunction
    Date Received
    January 17, 2020
    Date of Event
    November 6, 2019
    Report Date
    November 8, 2019
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FMG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING NORMAL ACTIVITY, THE T CONNECTOR EXTENSION SET BROKE APART. THIS LEFT THE CENTRAL LINE OPEN TO AIR AND PAIN MEDICATION WAS DELAYED. LINES WERE CLAMPED AND TUBING WAS IMMEDIATELY CHANGED. THIS OCCURRED ON AT LEAST THREE DIFFERENT NEONATAL PATIENTS. THE ORIGINAL PACKAGING WAS NOT SAVED, HOWEVER, THE FOLLOWING TWO LOT NUMBERS WERE FOUND ON THE REMAINING UNUSED STOCK: 4070982, 4088593. MANUFACTURER RESPONSE FOR 6"(15CM) APPX 0.42ML, SMALLBORE EXT SET W/CHECK VALVE, NANOCLAVE, NANOCLAVE T CONNECTOR, 2 CLAMPS, ROTATING LUER, (BRAND NOT PROVIDED) (PER SITE REPORTER). ICUMEDICAL DOES NOT HAVE A SUBSTITUTE TODAY BUT EXPECTS IT ON MONDAY AND WILL SHIP OVERNIGHT AS SOON AS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62756 MICROCLAVE STOPCOCK, I.V. SET FMG ICU MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 16 DA