BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3110156 · Received May 13, 2013

    Report

    Report Number
    1416980-2013-12215
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Report Date
    April 18, 2013
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. EVALUATION SUMMARY: THREE COMPANION SAMPLES WERE AVAILABLE FOR EVALUATION. THE COMPANION SAMPLES UNDERWENT VISUAL INSPECTION, AIR PASSAGE TESTING AND GRAVITY TESTING. NO ISSUES WERE FOUND DURING THE TESTING. THEREFORE THE REPORTED CONDITION COULD NOT BE CONFIRMED, NOR COULD A CAUSE BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SOLUTION ADMINISTRATION SET DID NOT ALLOW FLUID TO FLOW THROUGH EASILY. PATIENT INVOLVEMENT IS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211076 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 12K01V468

    Patients

    Seq Age Sex Outcome Treatment
    1