BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMODIALYSIS SET: 2-L 15 FR X 24 CM

    MDR report key: 1873335 · Received September 17, 2010

    Report

    Report Number
    1036844-2010-00282
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 13, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    MSD
    PMA / PMN Number
    K040078
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN DILATING THE VESSEL WITH THE 16FR DILATOR, THE SMARTSEAL SHEATH BEGAN TO SPLIT PREMATURELY. AS A RESULT, THE SHEATH WAS REMOVED AND WAS REPLACED WITH A BARD 16.5F PEEL-AWAY SHEATH AND THE CATHETER WAS SUCCESSFULLY INTRODUCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMODIALYSIS SET: 2-L 15 FR X 24 CM CHRONIC HEMODIALYSIS CATHETER PRODUCTS MSD ARROW INTL., INC. RF0062126

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR BARD 16.5 PEEL-AWAY SHEATH