BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD CONNECTOR

    MDR report key: 1151010 · Received August 28, 2008

    Report

    Report Number
    1018381-2008-00001
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    July 14, 2008
    Report Date
    August 4, 2008
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GCE
    PMA / PMN Number
    K912103
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE DEVICE WAS DISCARDED. A REP DEVICE FROM LOT #851155H WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE DEVICE WAS "BENT" RESULTING IN A DELAY IN CRITICAL THERAPY. THE DEVICE WAS BEING USED TO CROSS THE Y-SITE OF AN UNSPECIFIED TUBING SET THAT WAS DELIVERING AN UNSPECIFIED CONCENTRATION OF DOPAMINE AT A RATE OF 20MCG/KG/MIN. AFTER AN UNSPECIFIED LENGTH TO TIME AFTER THE Y-SITE WAS ACCESSED USING THE DEVICE, LEAKAGE WAS REPORTED FROM A "LARGE HOLE IN THE PORT" OF THE UNSPECIFIED TUBING SET. REPORTEDLY, "THE NEEDLE TIP IS BENT" AND A HOLE IN THE PORT WAS NOTED. IT WAS REPORTED THAT THE PT "DID NOT HAVE OPTIMAL BLOOD PRESSURE AS THE NEEDED MEDICATION WAS INFUSING ONTO THE BED." THE TUBING SET WAS REPLACED AND THERAPY WAS RESUMED. NO MEDICAL INTERVENTION WERE REQUIRED. THERE WERE NO REPORTED ADVERSE PT SEQUELAE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESHIELD CONNECTOR 79-GCE GCE ABBOTT LABORATORIES NA 73169HG

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other DOPAMINE| UNSPECIFIED TUBING SET