BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1970290 · Received January 14, 2011

    Report

    Report Number
    1036844-2011-00011
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 23, 2010
    Report Date
    January 11, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    FOZ
    PMA / PMN Number
    K993691
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 PROCEDURE WAS BEING PERFORMED IN THE NEURO INTENSIVE CARE UNIT. THE FELLOW WAS ATTEMPTING TO PLACE THE CENTRAL VENOUS CATHETER (CVC) FEMORALLY WHEN THE DRAPE BROKE AWAY TOO EARLY AND WITH LITTLE FORCE. THIS CAUSED THE PT'S PENIS TO FALL INTO THE STERILE FIELD. AS A RESULT, A SECOND KIT WAS OPENED AND THE NEW CATHETER WAS PLACED SUCCESSFULLY. IT IS UNK IF THERE WAS A DELAY IN TREATMENT AND NO PT DEATH. THE PT LATER CONTRACTED AN INFECTION. THE HOSPITAL IS NOT INSINUATING THAT THE BREAK IN THE BARRIER CAUSED THE INFECTION. BUT JUST THAT IT IS A POSSIBILITY. THE PT IS SEPTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LUMEN CVC KIT: 3-L 7 FR X 8 (20 C ARROWGARD CATHETER PRODUCTS FOZ ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other