BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3033926 · Received April 3, 2013

    Report

    Report Number
    1416980-2013-08334
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    November 20, 2012
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER REVIEW OF THE BATCH RECORDS, NO NONCONFORMANCE REPORT WAS DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT. THE SAMPLE WAS RECEIVED FOR EVALUATION. THE REPORTED CONDITION WAS CONFIRMED, AS A BROKEN LUER POST, THROUGH VISUAL INSPECTION. HOWEVER, THE CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL VOLUME INTERMATE WAS MISSING TWO INCHES OF TUBING ON THE LUER END OF THE SET. THIS MALFUNCTION WAS IDENTIFIED WHEN THE CUSTOMER WAS TAKING THE SET OUT OF THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, NOR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136036 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 12E023

    Patients

    Seq Age Sex Outcome Treatment
    1