BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4-WAY HIGH FLOW STOPCOCK

    MDR report key: 3952914 · Received July 9, 2014

    Report

    Report Number
    2025816-2014-00083
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    January 18, 2014
    Report Date
    March 20, 2014
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: A REVIEW OF THE MFG LOT BUILD DATABASE FOR THE REPORTED LOT# 2696284 (MFG DATE 06/2013) SHOWED (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILD. A TWO YEARS REVIEW OF THE COMPLAINT DATABASE FOR THIS LIST #B4018 RECORDED NO ADD'L REPORTS. FINDINGS: THE INVOLVED DEVICES/SET-UPS WERE NOT RETURNED FOR ANALYSIS AND VERIFICATION. THE EXACT CAUSE(S) OF THE REPORTED PRODUCT EXPERIENCES/ISSUES ARE UNK. THIS REPORT AND THE ASSOCIATED INFO HAVE BEEN ENTERED IN THE MFR'S DATABASE FOR ANALYSIS AND TRENDING. MEDSUN REPORT (B)(4) INCORRECTLY IDENTIFIED BAXTER HEALTHCARE AS THE MFR. UPON REVIEW AND ASSESSMENT, BAXTER HEALTHCARE CONTACTED AND FORWARDED THE MEDSUN REPORT TO ICU MEDICAL.

    Description of Event or Problem · 1

    MEDSUN REPORT INITIALLY PROCESSED TO BAXTER HEALTHCARE WHO FORWARDED THE REPORT TO ICU MEDICAL. MEDSUN REPORT RECEIVED CONCERNING BREAKAGE/LEAKAGE INCIDENT WITH USE OF B4018 4-WAY HIGH FLOW STOPCOCK WITH ROTATING LUER. THE REPORT STATES "NURSE ENTERED THE PT'S ROOM AND FOUND THE 4-WAY STOPCOCKS CRACKED AND LEAKING. IT APPEARED AS THOUGH THE PT WAS NOT RECEIVING MEDICATIONS DUE TO LEAK IN STOPCOCKS. THE PT WAS NOT HARMED". ALTHOUGH ADD'L EVENT AND USAGE INFO, AS WELL AS THE INVOLVED B4018 DEVICE WAS REQUESTED AS OF THE DATE OF THIS REPORT, RELEVANT INFO AND THE DEVICES HAVE NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400800 4-WAY HIGH FLOW STOPCOCK 4-WAY HIGH FLOW STOPCOCK FPA ICU MEDICAL, INC. B4018 2696284

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR