BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALLBORE EXTENSION SET WITH CLAMP/ROTATING LUER

    MDR report key: 20662038 · Received November 12, 2024

    Report

    Report Number
    20662038
    Event Type
    Malfunction
    Date Received
    November 12, 2024
    Date of Event
    August 4, 2024
    Report Date
    August 7, 2024
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FMG
    UDI-DI
    00887709094154
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    REGISTERED NURSE (RN) CHANGING LIPIDS AND TUBING. MEDICAL TUBING THAT IS ATTACHED TO PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE CRACKED UPON SWITCHING TUBING. LEAKING NOTICED RIGHT AWAY. NEONATAL NURSE PRACTITIONER (NNP) AT BEDSIDE TO ASSESS AND REPLACED MEDICAL TUBING WITH T-CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059426 SMALLBORE EXTENSION SET WITH CLAMP/ROTATING LUER FMG ICU MEDICAL, INC. 14402-28 13947271 00887709094154

    Patients

    Seq Age Sex Outcome Treatment
    1 6 DA Male