BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMINI ADMINISTRATION SET

    MDR report key: 2121172 · Received May 4, 2011

    Report

    Report Number
    9616066-2011-00139
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 5, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K934095
    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: (B)(4) 2011. (B)(4). ONE USED 2280-0000 SAMPLE FROM AN UNKNOWN LOT NUMBER WAS RECEIVED FOR INVESTIGATION. THE SYRINGE ADAPTOR AND THE UPPER PUMPING SEGMENT COMPONENT WERE THE ONLY COMPONENTS RECEIVED. THE REMAINDER OF THE SET IS PRESUMED TO HAVE BEEN DISCARDED BY THE CUSTOMER. THE SAMPLE HAD SNAPPED AT THE UPPER PUMPING SEGMENT COMPONENT WHICH CONFIRMED THE CUSTOMER'S FEEDBACK. EXAMINATION OF THE COMPONENT SHOWED THAT THERE WERE STRESS MARKS TO THE ONE SIDE SUGGESTING THAT THE BREAKAGE MAY HAVE OCCURRED DUE TO A SIDE-WAYS FORCE BEING APPLIED TO THE COMPONENT. ROOT CAUSE OF THE BREAKAGE WAS UNDETERMINED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE PRODUCT BROKE AT THE HUB BLUE CONNECTOR DURING USE. FROM THE REPORTED INFORMATION, THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PATIENT OR USER AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMINI ADMINISTRATION SET FPA CAREFUSION CORPORATION 2280-0000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK