BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3093336 · Received May 6, 2013

    Report

    Report Number
    1416980-2013-11374
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 15, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE AND ONE NON-BAXTER LUER ACTIVATED DEVICE FOR EVALUATION. VISUAL EXAMINATION OF THE BAXTER DEVICE SHOWED THAT THE MALE LUER WAS BROKEN OFF AND THAT THE MALE LUER SHAFT WAS INSIDE OF THE OPENING OF THE LUER ACTIVATED DEVICE. A FUNCTIONAL LEAK TEST WAS PERFORMED, WITH NO SIGNS OF LEAKAGE BEING OBSERVED ON THE REMAINDER OF THE SET. THE CAUSE OF THIS CONDITION WAS NOT DETERMINED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET WAS LEAKING HEPARIN FROM THE VALVE. IT IS UNKNOWN DURING WHAT PROCESS STEP THIS MALFUNCTION OCCURRED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195925 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1