BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 2-LUMEN 12 FR X 20 CM

    MDR report key: 1963606 · Received December 21, 2010

    Report

    Report Number
    1036844-2010-00373
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    December 10, 2010
    Report Date
    December 17, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    LFJ
    PMA / PMN Number
    K895417
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    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 THE CATHETER WAS INSERTED ON (B)(6) 2010, INTO AN (B)(6) OLD MALE PATIENT 23 DAYS PRIOR TO THIS OCCURRENCE IN THE DIALYSIS ROOM. ON (B)(6) 2010, WHILE IN THE HOSPITAL WARD, THE NURSE FOUND THE CATHETER LEAKING TWO PLACES ON THE PROXIMAL EXTENSION LINE AND STATED THAT THERE WAS NO LEAK, THE DAY BEFORE. AS A RESULT, A NEW KIT WAS OPENED AND USED WITHOUT ISSUE. THE MEDICATION BEING ADMINISTERED WAS HEPARIN AND THE INSERTION SITE WAS THE FEMORAL VEIN. THERE WAS NO REPORTED DELAY, DEATH OR COMPLICATIONS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 2-LUMEN 12 FR X 20 CM ACUTE HEMODIALYSIS CATHETER PRODUCTS LFJ ARROW INTL., INC. RF0021114

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR HEPARIN