BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 4260286 · Received November 18, 2014

    Report

    Report Number
    1416980-2014-41339
    Event Type
    Malfunction
    Date Received
    November 18, 2014
    Report Date
    October 20, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS MANUFACTURED APRIL 2, 2014 - APRIL 3, 2014. EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. BOTH THE FILL-PORT AND BLUE WINGED LUER CAPS WERE FOUND TO BE ATTACHED TO THE DEVICE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL VOLUME INTERMATE HAD AN UNSPECIFIED PROBLEM DESCRIBED AS THE DEVICE MISSING EITHER ITS BLUE TIP OR ITS TOP TIP. THIS WAS FOUND BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745959 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 14D013

    Patients

    Seq Age Sex Outcome Treatment
    1