BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 4033534 · Received August 25, 2014

    Report

    Report Number
    1416980-2014-27909
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Report Date
    July 30, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURE DATE: SEPTEMBER 22, 2013 - SEPTEMBER 23, 2013. EVALUATION: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION THE BLUE WINGED LUER CAP WAS OBSERVED TO HAVE SEPARATED FROM THE DISTAL LUER. THE REPORTED PROBLEM WAS VERIFIED. THE CAUSE OF THE PROBLEM IS UNKNOWN. 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 OF A LARGE VOLUME INTERMATE HAD DETACHED FROM THE DEVICE. THIS WAS FOUND BEFORE FILLING. THERE IS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513050 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 13J064

    Patients

    Seq Age Sex Outcome Treatment
    1