BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLINE SURECUFF INGROWTH CUFF SINGLE LUMEN 5F

    MDR report key: 2518301 · Received March 21, 2012

    Report

    Report Number
    2518301
    Event Type
    Malfunction
    Date Received
    March 21, 2012
    Date of Event
    March 19, 2012
    Report Date
    March 21, 2012
    Manufacturer
    BARD MEDICAL DIVISION
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    DIAGNOSTIC IMAGING WAS EXCHANGING A TUNNELED CENTRAL VENOUS CATHETER. WHEN THE NURSE PRACTITIONER PULLED THE OLD CATHETER OUT, THE CUFF CAME OFF THE CATHETER AND WAS STUCK IN THE PATIENT. THE CUFF HAD TO BE EXTRACTED MANUALLY. THIS CATHETER WAS INSERTED TOWARDS THE END OF LAST YEAR, AND THE PATIENT HAS RETURNED SO IT COULD BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINE SURECUFF INGROWTH CUFF SINGLE LUMEN 5F CATHETER, INTRAVASCULAR LJS BARD MEDICAL DIVISION * REVF0350

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR