BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN 3-L CATHETER

    MDR report key: 3894359 · Received February 19, 2014

    Report

    Report Number
    1036844-2014-00064
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    January 26, 2014
    Report Date
    January 27, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN WAS PLACING AN ARROW 18-GAUGE, 20CM, 7FR TRIPLE LUMEN CATHETER INTO THE 53 YEAR OLD FEMALE PATIENT'S FEMORAL VEIN IN THE EMERGENCY DEPARTMENT. THE PHYSICIAN WAS THREADING THE WIRE THROUGH THE NEEDLE. DILATION IS PROBABLY DONE AND THE CATHETER WAS PLACED OVER THE WIRE. AT WHICH TIME, THE WIRE STARTED TO UNRAVEL AND THEY WERE FORCED TO RESTART THE PROCEDURE. AFTER MULTIPLE INSERTION ATTEMPTS OF UNSUCCESSFUL PROBING, THE ULTRASOUND FROM THE ICU WAS OBTAINED AND THE CATHETER WAS PLACED USING ULTRASOUND. IT WAS SEEN IN PLACE WITH 2-0 ETHILON WITH GOOD FLOW. THE PATIENT TOLERATED THE PROCEDURE WELL. THERE WAS NO PATIENT DEATH OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105036 UNKNOWN 3-L CATHETER ADULT MULTI-LUMEN CATHETER PRODUCTS FOZ ARROW INTL., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR