BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 4260375 · Received November 18, 2014

    Report

    Report Number
    1416980-2014-41287
    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 FEBRUARY 19, 2014 - FEBRUARY 21, 2014. EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THE FILL-PORT CAP AND BLUE WINGED LUER CAP 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). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL VOLUME INTERMATE HAD AN UNSPECIFIED PROBLEM FURTHER DESCRIBED AS THE DEVICE MISSING THE BLUE TIP AND/OR THE TIP TOP. THIS WAS FOUND BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 5 OF 11.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744797 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 14B046

    Patients

    Seq Age Sex Outcome Treatment
    1