BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMINI ADMINISTRATION SET

    MDR report key: 1439526 · Received June 4, 2009

    Report

    Report Number
    9616066-2009-00288
    Event Type
    Malfunction
    Date Received
    June 4, 2009
    Date of Event
    March 20, 2009
    Report Date
    March 23, 2009
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FPA
    PMA / PMN Number
    K931173
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 06/04/2009.

    Description of Event or Problem · 1

    USER REPORTED A LEAKAGE OF FLUID FROM SMARTSITE VALVE DURING PRIMING. THIS EVENT OCCURRED PRIOR TO PT CONTACT. FURTHER INFORMATION ON THE EVENT HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMINI ADMINISTRATION SET FPA CARDINAL HEALTH ALARIS PRODUCTS 2401-0500 08096121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA