BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2092853 · Received May 11, 2011

    Report

    Report Number
    1036844-2011-00143
    Event Type
    Injury
    Date Received
    May 11, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 6, 2011
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K071538
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO PLACE THE CENTRAL VENOUS CATHETER (CVC) INTO THE PT'S SUBCLAVIAN IN THE SURGICAL INTENSIVE CARE UNIT (SICU). THE PHYSICIAN ATTEMPTED TO REMOVE THE NEEDLE WITH NORMAL TECHNIQUE AND THE NEEDLE BROKE OFF IN THE PT ABOUT 1MM ABOVE THE HUB. A CUT DOWN WAS PERFORMED TO REMOVE THE NEEDLE FROM UNDER THE SKIN. AS A RESULT, ANOTHER CVC WAS PLACED FOR THE PT. THERE WAS A DELAY IN TREATMENT, NO PT DEATH AND NO PT 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 INTERNATIONAL INC. RF1033366

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention