BEUDAMED
    FDA Adverse Event Death Summary report: N

    PSI KIT: 9 FR

    MDR report key: 2450013 · Received February 10, 2012

    Report

    Report Number
    1036844-2012-00042
    Event Type
    Death
    Date Received
    February 10, 2012
    Date of Event
    January 16, 2012
    Report Date
    February 10, 2012
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DYB
    PMA / PMN Number
    K780532
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SHEATH WAS BEING USED ON A MALE PATIENT IN THE EMERGENCY DEPARTMENT FOR A SUBCLAVIAN PLACEMENT. A KIT WAS OPENED AND THE PHYSICIAN TRIED TO ADVANCE THE DILATOR OVER THE BACK END OF THE SWG, AND THE WIRE WOULD NOT EXIT THE BACK END OF THE DILATOR. THE PHYSICIAN FELT AS IF THE BACK END OF THE DILATOR WAS SEALED OFF. AS A RESULT, A NEW KIT WAS OPENED BUT BY THAT TIME IT WAS TOO LATE AS THE PATIENT EXPIRED. THE PHYSICIAN STATED THE PATIENT WAS IN SUCH BAD SHAPE UPON ARRIVAL TO THE HOSPITAL. HE CANNOT BE SURE IF THE PATIENT EXPIRED DUE TO THE CHALLENGES WITH THE KITS OR DUE TO THE PATIENT'S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSI KIT: 9 FR CRITICAL CARE PSI PRODUCTS DYB ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death