BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2871346 · Received December 13, 2012

    Report

    Report Number
    1416980-2012-07189
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    July 7, 2012
    Report Date
    October 22, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K964850
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).. THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE CAN NOT BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Description of Event or Problem · 1

    A USER FACILITY MEDWATCH REPORT WAS SENT TO BAXTER CORPORATE PRODUCT SURVEILLANCE TO REPORT A CLEARLINK NON-DEHP FILTER EXTENSION SET IN WHICH THE "CONNECTIONS ARE NOT TIGHT ENOUGH". ACCORDING TO THE REPORT, THE BLUE HUBS ARE NOT TIGHT ENOUGH WHEN THE SETS ARE TAKEN OUT OF THE PACKAGE, RESULTING IN THE BLUE HUBS DISCONNECTING OFF THE IV. THE EVENT OCCURRED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT, INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R12A05011

    Patients

    Seq Age Sex Outcome Treatment
    1