BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2192762 · Received July 20, 2011

    Report

    Report Number
    1036844-2011-00242
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 14, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BURN UNIT WAS PLACING A CATHETER INTO THE PATIENT'S LEFT SUBCLAVIAN VEIN. THE SPRING WIRE GUIDE (SWG) WAS INSERTED EASILY INTO THE PATIENT WITH NO RESISTANCE. WHEN TRYING TO REMOVE THE SWG FROM THE CATHETER THE SWG BECAME UNRAVELED, BUT WAS REMOVED INTACT. AS A RESULT, A NEW KIT WAS OPENED AND PLACED SUCCESSFULLY. 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 MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8IN (2 ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTL., INC. RF1046257

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN