BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3051287 · Received April 10, 2013

    Report

    Report Number
    1416980-2013-08956
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 16, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K112893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS REQUESTED, HOWEVER THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. PER REVIEW OF THE BATCH RECORDS, NO NONCONFORMANCE REPORT WAS DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBING OF A CLEARLINK EXTENSION SET HAD SEPARATED FROM THE Y-SITE, RESULTING IN A LEAK. AFTER THIS MALFUNCTION WAS IDENTIFIED THE NUSE USED A NEW SET IN ORDER TO COMPLETE THERAPY ON THE PATIENT. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, NOR 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
    148361 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R13A07149

    Patients

    Seq Age Sex Outcome Treatment
    1