BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMODIALYSIS KIT: 2-L 15 FR X 24 CM

    MDR report key: 1150420 · Received September 5, 2008

    Report

    Report Number
    1036844-2008-00164
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 20, 2008
    Report Date
    September 5, 2008
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    MSD
    PMA / PMN Number
    K040078
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    F/U RPT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT THE DEVICE WAS BEING USED LEFT INTERNAL JUGULAR OF A MALE PATIENT. THE SMART SEAL SHEATH WOULD NOT PEEL AWAY PROPERLY AND BROKE LEAVING A 4 INCH PIECE INSIDE THE PATIENT. A SNARE WAS USED TO RETRIEVE THE BROKEN PIECE AND ANOTHER KIT WAS OPENED AND USED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMODIALYSIS KIT: 2-L 15 FR X 24 CM CHRONIC HEMODIALYSIS CATHETER PRODUCTS MSD ARROW INTERNATIONAL INC RL8067726

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention