BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3011535 · Received March 19, 2013

    Report

    Report Number
    1416980-2013-06613
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    February 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K921899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXACT DATE THAT THE EVENT OCCURED IS UNKNOWN. THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER FURTHER INVESTIGATION BY BAXTER (B)(4), THIS REPORT WAS FOUND TO BE A DUPLICATE REPORT OF MEDWATCH REPORT NUMBER 1416980-2013-04923. ALL PERTINENT INFORMATION WILL BE CONTAINED IN THE REFERENCED REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE INTERLINK SITE OF AN INTERLINK T CONNECTOR STD BORE DISCONNECTED FROM AN UNKNOWN SET BY ITSELF. THE REPORTED CONDITION OCCURRED DURING INFUSION. A PATIENT WAS INVOLVED, BUT THERE IS NO REPORT OF PATIENT/USER INJURY, OR MEDICAL INTERVENTION NEEDED IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113701 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO UR12K09047

    Patients

    Seq Age Sex Outcome Treatment
    1