BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3143304 · Received June 3, 2013

    Report

    Report Number
    1416980-2013-14126
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 10, 2013
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT AVAILABLE, AN EVALUATION COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RECONSTITUTION DEVICE LEAKED DURING RECONSTITUTION. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244146 ACCESS SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE - MALTA

    Patients

    Seq Age Sex Outcome Treatment
    1