BEUDAMED
    FDA Adverse Event Summary report: N

    SHAMROCK SAFETY BLOOD COLLECTION SET, 3/4" BUTTERFLY

    MDR report key: 13088 · Received May 5, 1994

    Report

    Report Number
    MW1001854
    Date Received
    May 5, 1994
    Date of Event
    March 26, 1994
    Manufacturer
    RYAN MEDICAL INC.
    Product Code
    JKA
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    RPTR STATES CLIENT WITH POOR CHOICE OF VENOUS ACCESS, REQUIRED MULTIPLE BLOOD SPECIMENS DRAWN. AFTER A FEW PUNCTURES OF BLOOD TUBES, THE SHEATHED NEEDLE PORT OF THE DEVICE DULLED. THE RED STOPPER OF THE COLLECTION TUBE WAS UNPLUGGED AND THE NEEDLE PORT SEAL WAS LOST CAUSING BLOOD TO LEAK. THE IV SITE HAD TO BE DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHAMROCK SAFETY BLOOD COLLECTION SET, 3/4" BUTTERFLY JKA RYAN MEDICAL INC. 10-1514

    Patients

    Seq Age Sex Outcome Treatment
    1 *