BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANGSTON

    MDR report key: 1821013 · Received August 31, 2010

    Report

    Report Number
    2134812-2010-00028
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 31, 2010
    Manufacturer
    VASCULAR SOLUTIONS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K051395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S ROOT CAUSE INVESTIGATION FOUND THAT THE MOST PROBABLE ROOT CAUSE OF THIS ISSUE WAS OPERATOR VARIANCE IN THE MANUFACTURING PROCEDURE PROCESS. SUBMISSION OF THIS REPORT DOES NOT REPRESENT A CONCLUSION OR ADMISSION BY VASCULAR SOLUTIONS, INC., THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE DEVICE FAILED OR MALFUNCTIONED IN ANY MANNER OR THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OF ANY PERSON.

    Description of Event or Problem · 1

    ACCOUNT REPORTED THAT ONE POUCH OF THE LANGSTON PIGTAIL CATHETER WAS NOT SEALED. THE CATHETER WAS NEVER USED ON THE PATIENT. NO PATIENT IMPACT WAS REPORTED BY THE ACCOUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANGSTON DUAL LUMEN CATHETER DQO VASCULAR SOLUTIONS, INC. 5540 548554

    Patients

    Seq Age Sex Outcome Treatment
    1