BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2871778 · Received December 13, 2012

    Report

    Report Number
    1416980-2012-07202
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K112893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE CAN NOT BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A SALES REP CALLED BAXTER CORPORATE PRODUCT SURVEILLANCE TO REPORT A CLEARLINK CATHETER EXTENSION SET WHICH LEAKED. ACCORDING TO THE REPORT, THE EXTENSION SET WAS CONNECTED TO A PICC LINE CATHETER. THE FACILITY WENT TO INJECT CONTRAST AT AN UNKNOWN RATE USING A POWER INJECTOR WHEN THE LEAK WAS NOTICED. IT APPEARED AS THOUGH SOLUTION LEAKED OUT EITHER BETWEEN THE CATHETER AND THE EXTENSION SET OR SOMEWHERE BETWEEN THE LUER OF THE EXTENSION SET AND ITS LUER. THE EVENT OCCURRED DURING PATIENT USE. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1