BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3080068 · Received April 26, 2013

    Report

    Report Number
    1416980-2013-10478
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ADDITIONAL RELEVANT INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN ANALYSIS COULD NOT BE PERFORMED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE FILTER OF A CLEARLINK SYSTEM SOLUTION SET, 20 DPM, DUO-VENT, 15 MICRON FILTER, 2 LUER ACTIVATED VALVES, MALE LUER LOCK ADAPTER WITH RETRACTABLE COLLAR "FLOATED FREE AND DISINTEGRATED. NURSE NOTICED WHITE PARTICLES FLOATING DOWN THE LINE". THE CONDITION OCCURRED DURING USE. A PATIENT WAS INVOLVED, BUT THERE IS NO REPORT OF PATIENT/USER INJURY OR MEDICAL INTERVENTION NEEDED IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180825 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE FR11108027

    Patients

    Seq Age Sex Outcome Treatment
    1