BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3081855 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10603
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LUER LOCK OF AN INTERMATE HAD BEEN PUSHED INTO THE INTERMATE. THIS WAS FOUND PRIOR TO USE. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183429 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 12N009

    Patients

    Seq Age Sex Outcome Treatment
    1