BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3831032 · Received May 23, 2014

    Report

    Report Number
    1416980-2014-16925
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Report Date
    May 1, 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). EVALUATION SUMMARY: THE SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION IDENTIFIED THAT THE BLUE WINGED LUER CAP WAS MISSING, VERIFYING THE REPORTED CONDITION. THE CAUSE OF THE MISSING COMPONENT IS UNKNOWN. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. 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). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF ANY RELEVANT INFORMATION IS OBTAINED THAT IS RELATED TO THE REPORTED EVENT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERMATE HAD A MISSING CAP. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307631 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 12H014

    Patients

    Seq Age Sex Outcome Treatment
    1