BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXT. SET

    MDR report key: 5647116 · Received May 11, 2016

    Report

    Report Number
    2025816-2016-00038
    Event Type
    Malfunction
    Date Received
    May 11, 2016
    Date of Event
    April 21, 2016
    Report Date
    May 11, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K941190
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL RECEIPT INSPECTION: 4/27/2016 - RECEIVED ONE (1) USED B2032, 60" SMALLBORE EXT SET, LOT# UNKNOWN. NO MATING DEVICES WERE RETURNED. THE FEMALE LUER WAS CONFIRMED TO BE CRACKED. FUNCTIONAL TESTING: A SINGLE USED B2032 EXTENSION SET WAS RETURNED FOR INVESTIGATION OF LEAKAGE. THE B2032 EXTENSION SET WAS PRESSURE TESTED USING A HYDROSTATIC PRESSURE VESSEL AT 10PSI. A LEAK WAS OBSERVED AT THE FEMALE LUER. MICROSCOPIC EXAMINATION OF THE FEMALE LUER REVEALED AN AXIAL CRACK AND A BROKEN LUER THREAD. THIS DAMAGE WAS THE CAUSE OF THE LEAKAGE. ANALYSIS SUMMARY: THE COMPLAINT OF B2032 EXTENSION SET LEAKAGE WAS CONFIRMED. THE LEAKAGE WAS THE RESULT OF AN AXIAL CRACK IN THE FEMALE LUER. ROOT CAUSE IS UNKNOWN. ICU MEDICAL WILL CONTINUE TO MONITOR AND TREND THIS FAILURE MODE.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING ONE B2032, 60" SMALLBORE EXT SET, LOT# UNKNOWN. REPORT STATES, "THE NURSE NOTICED AIR IN TUBING. WENT TO RE-PRIME TUBING AND NOTICED LIQUID SQUIRTING OUT OF THE SYRINGE CONNECTION. THREADS APPEAR TO BE BROKEN." NO SERIOUS PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303737 EXT. SET EXT. SET FPA ICU MEDICAL, INC. B2032 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1