BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4123607 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33526
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 3, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERLINK SOLUTION SET LEAKED FROM THE PORT. THIS OCCURRED DURING INFUSION OF AN UNKNOWN SOLUTION. THE REPORTER STATED THAT THE PATIENT LOST A MINIMAL AMOUNT OF BLOOD DUE TO THE EVENT; HOWEVER, THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 4 OF 15.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600017 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R13K05069

    Patients

    Seq Age Sex Outcome Treatment
    1