BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROBORE EXTENSION SET W/LL T-CONNECTOR

    MDR report key: 428239 · Received November 13, 2002

    Report

    Report Number
    9610175-2002-00011
    Event Type
    Malfunction
    Date Received
    November 13, 2002
    Date of Event
    October 21, 2002
    Report Date
    October 22, 2002
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED WHICH STATES, "STOPPER AND BAND DISCONNECTED FROM THE T-CONNECTOR". THE REPORT INDICATES ANOTHER MFR'S HIGH PRESSURE SET WAS CONNECTED TO THE EXTENSION SET. THE DEVICE WAS CONNECTED TO THE PT. THE INCIDENT OF THE RUBBER DISCONNECTION OCCURRED BEFORE THE THERAPY WAS INITIATED. THE PT DID NOT EXPERIENCE ANY ADVERSE EVENT OR REQUIRE ANY INTERVENTION. THE DEVICE WAS DISCONNECTED AND REMOVED. ALTHOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROBORE EXTENSION SET W/LL T-CONNECTOR ADMINISTRATION SET FPA ABBOTT LABORATORIES NA 89786VM

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other