BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 2-LUMEN 15 FR X 27 CM

    MDR report key: 2033884 · Received February 11, 2011

    Report

    Report Number
    1036844-2011-00054
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 8, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    MSD
    PMA / PMN Number
    K040666
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS BEING PERFORMED IN THE OPERATING ROOM. THE PHYSICIAN INSERTED THE DIALYSIS CATHETER. DURING TUNNELING, THE CATHETER AND TUNNELER CONNECTION WAS BROKEN AND THE PHYSICIAN WAS UNABLE TO RESTORE THE CONNECTION. AT THIS TIME, THE CATHETER WAS INSIDE THE TUNNEL TRACT. THE PHYSICIAN OPENED ANOTHER CATHETER TO RETRIEVE A NEW TUNNELER TO ATTEMPT TO PULL THE CATHETER THROUGH THE TRACT. ADD'L INFO RECEIVED ON (B)(6) 2011 FROM THE SALES REP STATED, THE CATHETER WAS BEING PLACED IN THE PT'S INTERNAL JUGULAR VEIN. IT IS UNK IF THERE WAS A DELAY IN TREATMENT. THERE WAS NO PT DEATH AND NO PT COMPLICATIONS REPORTED. THE CATHETER WAS SUCCESSFULLY PLACED USING THE THIRD KIT. REFERENCE MDR # 1036844-2011-00055 FOR THE SECOND EVENT INVOLVING THE SAME PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 2-LUMEN 15 FR X 27 CM CHRONIC HEMODIALYSIS CATHETER PRODUCTS MSD ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK