BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW INTERNATIONAL, INC.

    MDR report key: 15441 · Received February 17, 1994

    Report

    Report Number
    1930713-1994-00001
    Event Type
    Injury
    Date Received
    February 17, 1994
    Date of Event
    January 6, 1994
    Report Date
    January 10, 1994
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UPON REMOVAL OF SWAN GANZS CATHETER, THE NURSE NOTICED THAT THERE WAS AN EXCESSIVE AMOUNT OF FLUID AND BLOOD FLOWING OUT OF THE TOP OF THE HEMOSTASIS VALVE. UPON FURTHER INSPECTION THE VALVE HAD BEEN PULLED OUT OF THE PLASTIC HOUSING OF THE DISTAL TIP OF OUR TWIST LOCK CONTAMINATION SHIELD. WHEN THAT WAS PULLED BACK FROM THE THE HEMOSTASIS VALVE IT LEFT ONLY THE RUBBER VALVE IN PLACE, WHEN THE CATHETER WAS PULLED OUT IT DISLODGED THE VALVE OUT OF THE PLASTIC SIDEPORT HUB, LEAVING AN OPEN LINE INTO THE PT. PRODUCT WAS REMOVED FROM PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW INTERNATIONAL, INC. PERCUTANEOUS SHEATH INTRODUCER DYB ARROW INTERNATIONAL, INC. AK-91303A OR AK-92913 OR NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention