BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8IN (2

    MDR report key: 2193434 · Received July 13, 2011

    Report

    Report Number
    2242445-2011-00094
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K071538
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW UP REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS BEING PERFORMED IN THE TRAUMA EMERGENCY DEPARTMENT. DURING INSERTION, THEY EXPERIENCED AN ISSUE WITH THE SPRING WIRE GUIDE (SWG). ADD'L INFO RECEIVED ON (B)(4) 2011 FROM THE SALES REP STATED THAT DURING THE REMOVAL OF THE SWG, THE WIRE BEGAN TO UNRAVEL. THE PHYSICIAN WAS ABLE TO REMOVE THE ENTIRE SWG INTACT FROM THE PT. AS A RESULT, ANOTHER KIT WAS OPENED FOR A NEW SWG AND IT WAS USED FOR A SUCCESSFUL PLACEMENT. THERE WAS NO DELAY IN TREATMENT, NO PT DEATH AND NO PT COMPLICATIONS WERE REPORTED. THE PT OUTCOME WAS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8IN (2 ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTL., INC. MF0126559

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK