BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2880207 · Received December 19, 2012

    Report

    Report Number
    1416980-2012-07747
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    December 1, 2012
    Report Date
    December 4, 2012
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - EVALUATION IS PENDING UPON RECEIPT OF THE SAMPLE. UPON COMPLETION OF THE EVALUATION, OR SHOULD ANY ADDITIONAL INFORMATION BE MADE AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. THE CUSTOMER REPORTED CONDITION WAS CONFIRMED AND THE ROOT CAUSE WAS IDENTIFIED AS A LOOSE CAP DUE TO OPERATOR OVERSIGHT. AWARENESS TRAINING WAS PERFORMED AS A CORRECTIVE ACTION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO A BAXTER REPRESENTATIVE A CONDITION OF AN INTERMATE DISPOSABLE SOLUTION DELIVERY SYSTEM THAT WAS ALLEGED WITH A LOOSE BLUE LUER CAP. THE LUER CAP WAS REPORTED TO BE LOOSE WITHIN THE PACKAGING. THERE WAS NO REPORT OF PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT. THIS IS REPORT 5 OF 6 INVOLVING THIS CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 12F042

    Patients

    Seq Age Sex Outcome Treatment
    1