BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMODIALYSIS KIT: 2-L 15 FR X 28 CM

    MDR report key: 2211813 · Received July 20, 2011

    Report

    Report Number
    1036844-2011-00252
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 19, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    MSD
    PMA / PMN Number
    K040078
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE RADIOLOGY DEPARTMENT THE SPRING WIRE GUIDE (SWG) WAS INSERTED VIA THE PT'S RIGHT INTERNAL JUGULAR VEIN. IT WAS REPORTED THAT THE SMART-SEAL SHEATH DID NOT HAVE VALVES TO PREVENT BLEED BACK OR THE POSSIBILITY OF AN AIR EMBOLISM. A SECOND KIT WAS OPENED AND THE SMART-SEAL FROM THAT KIT WAS USED TO FINISH THE PROCEDURE. THERE WAS NO REPORTED INJURY, COMPLICATION, OR DEATH FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMODIALYSIS KIT: 2-L 15 FR X 28 CM CHRONIC HEMODIALYSIS CATHETER PRODUCTS MSD ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK