BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 3-LUMEN 7 FR X 20 CM

    MDR report key: 2201455 · Received August 3, 2011

    Report

    Report Number
    1036844-2011-00267
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    June 30, 2011
    Report Date
    August 2, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K993691
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS BEING PLACED IN THE EMERGENCY DEPARTMENT. DURING PLACEMENT INTO THE PATIENT'S RIGHT SUBCLAVIAN, THE PHYSICIAN INSERTED THE ACCESS NEEDLE AND ADVANCED THE SPRING WIRE GUIDE (SWG). THE SWG STARTED TO KINK WHEN THREADING THE CATHETER OVER THE SWG AND SO THE PHYSICIAN BEGAN TO REMOVE EVERYTHING. BOTH THE CATHETER AND SWG WERE REMOVED FROM THE PATIENT AS ONE. IT WAS DISCOVERED THAT THE SWG HAD BECOME SEPARATED INSIDE THE CATHETER, BUT WAS CONTAINED WITHIN THE CATHETER. AS A RESULT, ANOTHER KIT WAS OPENED AND PLACED SUCCESSFULLY FOR THE PATIENT USING A NEW INSERTION SITE. THERE WAS A DELAY IN TREATMENT WITH NO HARM TO THE PATIENT. THERE WAS NO PATIENT DEATH AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 3-LUMEN 7 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTL., INC. RF1010866

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK