BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3203655 · Received July 3, 2013

    Report

    Report Number
    1416980-2013-17122
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    May 24, 2013
    Report Date
    June 8, 2013
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FMG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. ONE DEVICE WAS EVALUATED AGAINST THE REPORTED CONDITION OF A DAMAGED STOPCOCK LUER. THE DEVICE WAS VISUAL INSPECTED AND THE REPORTED CONDITION WAS CONFIRMED. SEVERAL CRACKS ON THE DEVICE WERE NOTED. NO CAUSE COULD BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LUER ON A STOPCOCK WAS DAMAGED, AFTER 2 DAYS OF PATIENT USE. THE DAMAGE WAS REPORTED TO BE A CRACK, WHICH RESULTED IN A SMALL AMOUNT OF BLOOD LOSS. THERE WAS NO REPORT OF ADVERSE EVENT ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 3 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304363 ACCESS STOPCOCK, I.V. SET FMG BAXTER HEALTHCARE - MALTA 12G31V194

    Patients

    Seq Age Sex Outcome Treatment
    1