BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3243544 · Received July 23, 2013

    Report

    Report Number
    1416980-2013-19499
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    June 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FMG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ONE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION REVEALED THAT THE CLAMP HAD THE ROLLER MISSING. FURTHERMORE, THE CLAMP WAS FOUND TO BE DAMAGED. HOWEVER, THE CAUSE FOR THIS ISSUE COULD NOT BE IDENTIFIED. A BATCH REVIEW WAS PERFORMED AND NO ISSUES OR ABERRANCIES WERE NOTED DURING THE MANUFACTURING OF THIS LOT. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ROLLER CLAMP OF A SOLUTION ADMINISTRATION, DEHP FREE WITH THREE WAY STOPCOCK, SET HAD BROKEN. THE REPORTED CONDITION OCCURRED DURING INFUSION ON A PATIENT AND CAUSED AN UNCONTROLLED FLOW. HOWEVER, THERE IS NO REPORT OF ADVERSE EVENT REPORTED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342599 ACCESS STOPCOCK, I.V. SET FMG BAXTER HEALTHCARE - MALTA 13B28V473

    Patients

    Seq Age Sex Outcome Treatment
    1