BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2972924 · Received February 21, 2013

    Report

    Report Number
    1416980-2013-04391
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 31, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED; THE REPORTED CONDITION HAS BEEN CONFIRMED. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. A VISUAL EXAMINATION CONFIRMED THE REPORTED CONDITION OF A BROKEN DISTAL LUER. THE LUER POST WAS BROKEN OFF AT THE BASE OF THE STEM NEAR THE TUBING. HOWEVER, THE CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE SAMPLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERMATE LV WAS FOUND WITH A CRACKED LUER LOCK. THIS MALFUNCTION WAS REPORTED TO HAVE BEEN OBSERVED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75707 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 12J052

    Patients

    Seq Age Sex Outcome Treatment
    1