BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LUMEN CVC KIT: 3-L 7 FR X 8 (20 C

    MDR report key: 1881111 · Received October 1, 2010

    Report

    Report Number
    1036844-2010-00308
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 28, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K993691
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS PLACING THE CATHETER FEMORALLY. UPON REMOVAL OF THE SPRING WIRE GUIDE (SWG) THROUGH THE DISTAL PORT, THE SWG WAS UNCOILED AND CAUSED THEM TO ABORT THE PROCEDURE. IT IS UNK HOW LONG THE DELAY IN TREATMENT WAS, NO PT DEATH, AND NO COMPLICATIONS REPORTED. ADDITIONAL INFO RECEIVED ON (B)(6) 2010 FROM THE HOSPITAL STATED THEY MADE A FEW ATTEMPTS TO INSERT A CENTRAL VENOUS CATHETER (CVC), FIRST IN THE SUBCLAVIAN AND THEN IN THE INTERNAL JUGULAR BEFORE GOING TO THE FEMORAL SITE. THE CLINICIAN DOES NOT KNOW IF RESISTANCE WAS FELT DURING INSERTION, BUT WHEN REMOVING THE SWG IT BEGAN TO UNRAVEL. AS A RESULT, BOTH THE CATHETER AND SWG WERE REMOVED AS ONE AND THE PROCEDURE WAS ABORTED. THERE WAS NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LUMEN CVC KIT: 3-L 7 FR X 8 (20 C ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTL., INC. RF0060792

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK