BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2893897 · Received January 2, 2013

    Report

    Report Number
    1416980-2012-06980
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    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 SUMMARY: THE REPORTED CONDITION WAS CONFIRMED, DURING VISUAL INSPECTION OF THE RETURNED SAMPLE. THE ROOT CAUSE WAS DETERMINED TO BE A LOOSE CAP DUE TO OPERATOR OVERSIGHT. SHOULD ANY ADDITIONAL INFORMATION BE MADE AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO A BAXTER REPRESENTATIVE A CONDITION OF AN INTERMATE DISPOSABLE DRUG 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 #4 OF 6 INVOLVING THIS CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1