BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3252945 · Received July 29, 2013

    Report

    Report Number
    1416980-2013-20070
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Report Date
    July 4, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE SAMPLE WAS NOT RETURNED; THEREFORE, AN EVALUATION COULD NOT BE PERFORMED. A BATCH REVIEW WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE Y-PORT OF AN INTERLINK SYSTEM CONTINU-FLO SOLUTION SET WAS INACCESSIBLE WHEN USED WITH AN INTERLINK CONNECTOR. THE CUSTOMER STATED THAT THE CANNULA WOULD NOT PIERCE THE MEMBRANE. THIS ISSUE WAS DISCOVERED DURING INFUSION OF AN UNKNOWN DRUG. THE CUSTOMER STATED THAT THEY SET UP THE DEVICE WITH NEW SUPPLIES TO CONTINUE THERAPY. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352206 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R13B04169

    Patients

    Seq Age Sex Outcome Treatment
    1