BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2599285 · Received June 5, 2012

    Report

    Report Number
    6000001-2012-11366
    Event Type
    Malfunction
    Date Received
    June 5, 2012
    Date of Event
    January 23, 2012
    Report Date
    May 30, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. - ATTACHMENT: (B)(4).

    Description of Event or Problem · 1

    THE DEPARTMENT OF HEALTH AND HUMAN SERVICES SENT NOTIFICATION OF A MEDWATCH TO BAXTER CORPORATE PRODUCT SURVEILLANCE ABOUT A CLEARLINK CONTINU-FLO SOLUTION SET IN WHICH PARTICULATE MATTER WAS OBSERVED IN THE TUBING. ACCORDING TO THE REPORT, THE PATIENT NOTICED THAT THERE WAS SOMETHING IN THE IV TUBING THAT LOOKED LIKE A BUG. THE PATIENT PINCHED OFF THE TUBING BEFORE THE PARTICULATE MATTER HAD A CHANCE TO ENTER THE VEIN. THE SET WAS IN USE WITH A 1000ML 0.9% BAG OF NORMAL SALINE (LOT # C855361). THERE WERE NO REPORTS OF PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 1000ML 0.9% BAG OF NORMAL SALINE