BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET 20 IN STERILE PACK

    MDR report key: 490689 · Received October 16, 2003

    Report

    Report Number
    9613251-2003-00183
    Event Type
    Malfunction
    Date Received
    October 16, 2003
    Date of Event
    September 1, 2003
    Report Date
    September 24, 2003
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNDOCUMENTED NUMBER OF UNDOCUMENTED INCIDENTS OF IV EXTENSION SETS DISCONNECTING FROM THE IV ACCESS DEVICE. THE CUSTOMER REPORTED THESE INCIDENTS "OCCURRED ONCE OR TWICE A WEEK FOR THE PAST MONTH" WITH PTS UNDERGOING UNSPECIFIED SURGICAL PROCEDURES. THE IV SITES WERE ACCESSED, AND THE CLINICIAN CONNECTED THE EXTENSION SETS TO THE IV ACCESS DEVICE. IMMEDIATELY UPON INITIATION OF FLOW, IT WAS NOTED THAT THE EXTENSION SETS TO ACCESS DEVICE CONNECTIONS WERE LEAKING. UPON INSPECTION BY THE CLINICIAN, IT WAS NOTED THAT THE MALE ADAPTOR OF THE EXTENSION SETS WERE NOT SEATED SECURELY IN THE 20G IV ANGIOCATH. THIS RESULTED IN "LESS THAN 1 CC" OF BLOOD LOSS THAT LEAKED OVER THE PTS' HANDS, AND AN UNSPECIFIED AMOUNT OF IV FLUID LEAKAGE. THE EXTENSION TUBING SETS WERE REPLACED. THE CUSTOMER REPORTED THERE WERE NO DELAYS IN CRITICAL THERAPY AND NO ADVERSE PT EFFECTS. ALTHOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION SET 20 IN STERILE PACK ADMINISTRATION SET FPA ABBOTT LABORATORIES NA 06094NS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other INSYTE 20G ANGIOCATH, MFG BY BECTON DICKINSON.