BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3932780 · Received July 14, 2014

    Report

    Report Number
    1416980-2014-22561
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS LOT WAS MANUFACTURED BETWEEN MARCH 21, 2014 ¿ MARCH 24, 2014. THE SAMPLE WAS NOT RETURNED FOR EVALUATION, THEREFORE THE REPORTED CONDITION COULD NOT BE VERIFIED AND THE CAUSE COULD NOT BE IDENTIFIED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLUE WINGED LUER CAP ON A SMALL VOLUME INTERMATE BROKE DURING MANIPULATION. THIS OCCURRED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409437 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 14C050

    Patients

    Seq Age Sex Outcome Treatment
    1