BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMODIALYSIS KIT: 2-L 15 FR X 32CM

    MDR report key: 1021990 · Received March 31, 2008

    Report

    Report Number
    1036844-2008-00051
    Event Type
    Injury
    Date Received
    March 31, 2008
    Date of Event
    March 12, 2008
    Report Date
    March 31, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    MSD
    PMA / PMN Number
    K040078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY MD THAT THE CATHETER WAS INSERTED IN PTS' LEFT INTERNAL JUGULAR IN 2008 WITHOUT COMPLICATIONS. IT WAS REPORTED TO MD THAT THE DIALYSIS UNIT COULD ONLY DIALYSIS THROUGH CATHETER AT 180 CC & FOR THE LAST 10 DAYS IT WAS NOT WORKING PROPERLY. MD PERFORMED FLUOROSCOPY & SAW CATHETER V-TIP HAD BECOME DISCONNECTED FROM THE TIP OF THE CATHETER. MD STATED "HE CAN NOT REMOVE IT TODAY AND THAT TOMORROW HE IS GOING TO BE IN A DIFFERENT HOSP." HE STATED HIS PARTNER WOULD LOOK AT IT TODAY & IF HE WAS NOT COMFORTABLE REMOVING IT, THEY WERE GOING TO TRANSPORT PT TO ANOTHER HOSP. THE SALES REP ASKED IF MD NEEDED ANY ADVISE ON REMOVING CATHETER. MD SAID THAT WAS NOT NECESSARY; HE COULD JUST GO IN AND SNAG THE TIPS. MD STATED HE WAS COMFORTABLE DOING THIS AND IT WAS NOT AN ISSUE. THE PT WAS TRANSFERRED TO ANOTHER HOSP ON THE FOLLOWING MONTH AS AN OUT-PT, AND ON THE SAME DAY, THE CATHETER WAS REMOVED. THE PT IS DOING FINE AND THE CATHETER CAME OUT SMOOTHLY. THE SALES REP WAS CONTACTED WHEN CATHETER WAS REMOVED SO PRODUCT COULD BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMODIALYSIS KIT: 2-L 15 FR X 32CM CHRONIC HEMODIALYSIS CATHETER PRODUCTS MSD ARROW INTL., INC. RL7013950

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention