BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4130416 · Received September 30, 2014

    Report

    Report Number
    1416980-2014-33922
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Report Date
    September 5, 2014
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS DIFFICULT TO DRAW BLOOD THROUGH AN UNKNOWN ONE-LINK EXTENSION SET. IT WAS NOT SPECIFIED WHEN IN THE PROCESS THIS OCCURRED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO REPORT OF 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
    609420 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1