BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANGSTON DUAL-LUMEN PIGTAIL CATHETER

    MDR report key: 1862578 · Received October 8, 2010

    Report

    Report Number
    2134812-2010-00032
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 10, 2010
    Report Date
    October 8, 2010
    Manufacturer
    VASCULAR SOLUTIONS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K051395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCOUNT REPORTED THE LANGSTON DUAL-LUMEN PIGTAIL CATHETER APPEARED SHEARED UPON OPENING THE CATHETER PACKAGE. ADDITIONAL INFORMATION OBTAINED FROM THE REPORTING ACCOUNT NOTED THE PRODUCT WAS NOT USED IN A PATIENT PROCEDURE. HOWEVER, UPON RECEIPT OF THE PRODUCT, MANUFACTURER FOUND BLOOD ON THE INSIDE AND OUTSIDE LUMEN INDICATING PROCEDURAL USE. FURTHER CONTACT WITH THE ACCOUNT TO DISCUSS INCONSISTENCIES IN THE REPORT AND MANUFACTURER'S FINDINGS RESULTED IN ACCOUNT CONFIRMING THE DEVICE WAS NOT USED IN A PATIENT PROCEDURE. ADDITIONALLY, THE CONDITION OF THE RETURNED LANGSTON SHOWS EXTENSIVE DAMAGE, POSSIBLY THE RESULT OF HIGH-PRESSURE INJECTION. BASED UPON THE DIFFERENCES BETWEEN MANUFACTURER'S INVESTIGATION, MANUFACTURER IS UNABLE TO DRAW A CONCLUSION ON THE REPORTED EVENT.

    Description of Event or Problem · 1

    ACCOUNT REPORTED THAT UPON OPENING THE PRODUCT PACKAGE, THE TECHNICIAN NOTICED THAT THE LANGSTON DUAL-LUMEN PIGTAIL CATHETER APPEARED TO BE SHEARED. NO PATIENT IMPACT WAS REPORTED BY THE ACCOUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANGSTON DUAL-LUMEN PIGTAIL CATHETER INTRAVASCULAR DIAGNOSTIC CATHETER DQO VASCULAR SOLUTIONS, INC. 5540 549116

    Patients

    Seq Age Sex Outcome Treatment
    1