BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4-WAY STANDARD BORE STOPCOCK

    MDR report key: 1161421 · Received September 17, 2008

    Report

    Report Number
    6000001-2007-00562
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    December 1, 2006
    Report Date
    December 13, 2006
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA ON JAN 05 2007. DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    ANESTHESIOLOGIST REPORTED SEVERAL INCIDENTS OF LEAKING WITH THIS STOPCOCK. ONE INCIDENT REPORTED OR OR ON A PROPOFOL PUMP. NO ADDITIONAL INFORMATION IS AVAILABLE ON THE OTHER INCIDENTS. PRODUCT SURVEILLANCE HAS MADE NUMEROUS ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS REPORTED EVENT. NO PATIENT INJURY HAS BEEN REPORTED. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED ON THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4-WAY STANDARD BORE STOPCOCK IV STOPCOCK FPA BAXTER HEALTHCARE CORPORATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 PROPOFOL PUMP