BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCANLAN ULTIMATE SINGLE-USE VEIN PUNCH

    MDR report key: 2794414 · Received October 11, 2012

    Report

    Report Number
    2126670-2012-00004
    Event Type
    Malfunction
    Date Received
    October 11, 2012
    Date of Event
    September 11, 2012
    Report Date
    October 11, 2012
    Manufacturer
    SCANLAN INTERNATIONAL, INC.
    Product Code
    DWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND INSPECTED. THE TIP IS NOT BROKEN. FOREIGN MATERIAL WAS FOUND IN THE PACKAGE AND WE ARE INVESTIGATING THE SOURCE. SCANLAN INTERNATIONAL, INC. HAS MADE NUMEROUS ATTEMPTS TO GAIN FURTHER INFORMATION REGARDING THIS REPORTED EVENT. THE CONTACT POINT IS A RISK MANAGER WITH NO DIRECT KNOWLEDGE OF THE EVENT. UNABLE TO CONTACT PRACTITIONERS WHO REPORTED THE EVENT.

    Description of Event or Problem · 1

    THE TIP BROKE OFF IN THE PT WHILE DOING A CABG. AS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCANLAN ULTIMATE SINGLE-USE VEIN PUNCH SINGLE-USE VEIN PUNCH DWS SCANLAN INTERNATIONAL, INC. 1001-622 5110201

    Patients

    Seq Age Sex Outcome Treatment
    1