BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3853368 · Received June 6, 2014

    Report

    Report Number
    1416980-2014-18156
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 13, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. HOWEVER, THE USE OF A NEEDLE TO ACCESS THE CLEARLINK PORT WAS REPORTED AND IS A KNOWN CAUSE OF DAMAGE TO THE PORT. THE LABELING OF THIS PRODUCT'S PACKAGING STATES "DO NOT "ACCESS CLEARLINK VALVE WITH NEEDLES OR CANNULA." "ATTEMPTING SUCH ACCESS WILL RENDER THE PRODUCT DAMAGED, REPLACE IMMEDIATELY." A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY 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 A CLEARLINK SYSTEM CONTINU-FLO SET LEAKED FROM ITS CLEARLINK PORT WHEN THE OPERATOR ATTEMPTED TO ACCESS IT WITH A NEEDLE. THIS OCCURRED DURING PATIENT INFUSION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332003 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1