BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIFURCATED CLAVE EXTENSION SET

    MDR report key: 134524 · Received November 20, 1997

    Report

    Report Number
    2025816-1997-00026
    Event Type
    Malfunction
    Date Received
    November 20, 1997
    Date of Event
    October 26, 1997
    Report Date
    November 7, 1997
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE TUBING OF THE B9027 EXTENSION SET SEPARATED FROM THE MALE LUER CONNECTION. PT WAS RECEIVING AN INFUSION THROUGH A CENTRAL LINE, USING AN IVAC PUMP, AND LOST APPROX ONE OUNCE OF BLOOD. NO PT INJURY, BUT MEDICAL INTERVENTION WAS REQUIRED. HOSP HAS NOT RELEASED DEVICE FOR EVAL, BUT AN ICU MEDICAL PRODUCT SPECIALIST VIEWED THE DEVICE AND STATED IT APPEARED THAT THE TUBING HAD PULLED OUT OF THE MALE LUER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIFURCATED CLAVE EXTENSION SET CLAVE EXTENSION SET FPA ICU MEDICAL, INC. NA B7B019

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention IVAC INFUSION PUMP, SWAN GANZ