BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIROS CONNECTOR

    MDR report key: 1755214 · Received June 29, 2010

    Report

    Report Number
    2025816-2010-00059
    Event Type
    Malfunction
    Date Received
    June 29, 2010
    Date of Event
    February 25, 2010
    Report Date
    March 4, 2010
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    COMPLAINT REC'D REPORTING A LEAKAGE PROBLEM WITH ONE (1) 20130-01 SPIROS CONNECTORS W/CAP. IT WAS REPORTED THAT "VINCRISTINE WAS BEING ADMINISTERED TO PT VIA PORT. WHEN MEDICATION WAS INITIALLY STARTED, RN NOTICED SMALL DRIP/LEAK OF MEDICATION AT SITE OF SPIROS CONNECTION....FULL DOSE OF MEDICATION WAS GIVEN AND NO OTHER ACTIONS TAKEN AS LEAK/DRIP WAS VERY MINIMAL AMOUNT, 1-2 DROPS NOTED... WAS ABSORBED INTO THE WHITE CHEMO PAD. PT DID NOT HAVE ANY CONTACT WITH LEAK/MEDICATION. ADD'L INCIDENT INFORMATION: RN ALSO REPORTED THAT WHEN DRAWING BACK THE SYRINGE FOR BLOOD RETURN CHECK, RN OBSERVED AIR WAS PRESENT IN SYRINGE. THERE WERE NO REPORTED ADVERSE PT CONSEQUENCES. THE INVOLVED 20130-01 DEVICE WAS DISCARDED. EXACT CAUSE OF THE REPORTED EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIROS CONNECTOR CONNECTOR FPA ICU MEDICAL, INC. 20130-01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI SYRINGE NOI (MFGER, MAKE, MODEL UNKNOWN)