BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3973429 · Received August 1, 2014

    Report

    Report Number
    1416980-2014-25084
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL
    Product Code
    FPA
    PMA / PMN Number
    K123874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY FLOW TESTED WITH NO DEFECTS NOTED. THE REPORTED PROBLEM WAS NOT VERIFIED, AS THE DEVICE OPERATED WITHIN THE DESIRED PRODUCT SPECIFICATIONS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BURETROL SOLUTION SET CONTAINING SALINE DISCONNECTED FROM THE DRIP CHAMBER. THIS OCCURRED AFTER IT WAS USED WITH A PATIENT. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451160 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL

    Patients

    Seq Age Sex Outcome Treatment
    1