BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANGEL WING MULTI-SAMPLE COLLECTION SET (MALE)

    MDR report key: 300127 · Received October 11, 2000

    Report

    Report Number
    9610849-2000-00025
    Event Type
    Other
    Date Received
    October 11, 2000
    Report Date
    October 11, 2000
    Manufacturer
    THE KENDALL COMPANY
    Product Code
    GJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON SEVERAL OCCASIONS WHEN INSERTING AND REMOVING THE BLOOD COLLECTION TUBE FROM THE COLLECTION SET, THE RUBBER SHEATH ON THE "BUTTEND" OF THE NEEDLE IS NOT COVERING THE NEEDLE (ON THE REMOVAL OF THE TUBE). THIS CAUSES BLOOD TO SPILL OUT AND AN INFECTION CONTROL ISSUE IS CREATED. THIS IS HAPPENING WHEN CONNECTED TO AN ANGEL WING BUTTERFLY SET. THE SHEATH STAYING UP TENDS TO OCCUR ON THE REMOVAL OF THE SECOND BLOOD COLLECTION TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGEL WING MULTI-SAMPLE COLLECTION SET (MALE) BLOOD COLLECTION SET GJE THE KENDALL COMPANY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other