BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3172033 · Received June 17, 2013

    Report

    Report Number
    1416980-2013-15491
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K112893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEARLINK LUER ACTIVATED VALVE REMAINED DEPRESSED AND LEAKED AFTER REPEATED ACCESS. THE REPORTER SPECIFIED THAT THE VALVE WAS ACCESSED LESS THAN 200 TIMES. THIS MALFUNCTION OCCURRED WHILE THE NURSE EDUCATOR(S) REVIEWED STERILE CAP CHANGES WITH THE CLINICAL STAFF. THE OBSERVATION WAS MADE AFTER APPROXIMATELY FIVE CLINICIANS ACCESSED THE SITE. THE VALVE REMAINED DEPRESSED, RESULTING IN THE VALVE LEAKING WHEN TURNED OVER AND SHAKEN. 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
    274393 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1