BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4121328 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33329
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 2, 2014
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K112893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION COULD NOT BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEARLINK CATHETER EXTENSION SET LEAKED FROM A CRACKED ¿CONNECTOR.¿ IT WAS REPORTED THAT THE EVENT OCCURRED WHEN A REGISTERED NURSE (RN) CONNECTED THE SET TO A 5ML SYRINGE WHEN FLUSHING AN IV START. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601887 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 5ML SYRINGE