BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAMROCK SAFETY BLOOD COLLECTION SET

    MDR report key: 74680 · Received March 7, 1997

    Report

    Report Number
    MW1010912
    Event Type
    Malfunction
    Date Received
    March 7, 1997
    Manufacturer
    RYAN MEDICAL, INC.
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    VENIPUNCTURE DONE WITH GOOD BLOOD RETURN OBTAINED. COLLECTION TUBE WOULDN'T FILL AND THE NURSE NOTED LEAKAGE OF BLOOD FROM A TINY TEAR IN THE TUBING AT THE DISTAL END OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHAMROCK SAFETY BLOOD COLLECTION SET BLOOD COLLECTION SET JKA RYAN MEDICAL, INC. * D0081

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR