BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3171766 · Received June 17, 2013

    Report

    Report Number
    1416980-2013-15487
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 22, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. 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 AN SMALL VOLUME INTERMATE DEVICE HAD A SEPARATED DISTAL LUER. THE REPORTER STATED THAT THE TUBING BECAME DETACHED FROM THE PLASTIC AT THE BOTTOM OF THE LUER. THE EVENT WAS IDENTIFIED BY THE PATIENT PRIOR TO USE. THERE WAS NO ADVERSE EVENT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE. THIS IS REPORT THREE OF THREE FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272771 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE

    Patients

    Seq Age Sex Outcome Treatment
    1