BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3241070 · Received July 22, 2013

    Report

    Report Number
    1416980-2013-19307
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    June 27, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K112893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. EVALUATION SUMMARY: A COMPANION SAMPLE AND THE NON-BAXTER EXTENSION SET WERE RECEIVED FOR EVALUATION. A VISUAL INSPECTION OF THE SETS WAS PERFORMED. THE SAMPLES WERE SUBJECTED TO PRESSURE TESTING AND LEAK TESTED. THE SET PASSED ALL TESTS; NO MALFUNCTIONS WERE FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4). IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEARLINK EXTENSION SET HAD COMPATIBILITY ISSUES WITH A NON-BAXTER EXTENSION SET RESULTING IN A LEAK. THIS OCCURRED DURING INFUSION. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340450 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R13C23043

    Patients

    Seq Age Sex Outcome Treatment
    1 ACACIA HR-016 NEEDLELESS VALVE EXTENSION SET