BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5 FR POWERLINE CATHETER, MICROINTRODUCER KIT

    MDR report key: 2113569 · Received June 1, 2011

    Report

    Report Number
    3006260740-2011-00162
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 25, 2011
    Manufacturer
    C. R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K050185
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF A DISLODGED SURECUFF IS CONFIRMED. UPON RECEIPT, THE SURECUFF IS MISSING FROM THE CATHETER. GROSS AND MICROSCOPIC EXAMINATIONS SHOWED GLUE MATERIAL ADHERING TO THE CATHETER WHERE THE SURECUFF WOULD BE LOCATED ON THE CATHETER. AT THIS TIME, THE MECHANISM OF DAMAGE IS UNDETERMINED. A LHR IS NOT POSSIBLE, AS NO MFG LOT NUMBER INFO HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    CUFF SEPARATION. THE POWERLINE CAME OUT WITHOUT THE CUFF ATTACHED. HAD TO DO A CUT-DOWN AND EXPLORATION TO LOCATE AND REMOVE THE CUFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5 FR POWERLINE CATHETER, MICROINTRODUCER KIT LJS C. R. BARD, INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention