BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 1100552 · Received August 5, 2008

    Report

    Report Number
    MW5007898
    Event Type
    Malfunction
    Date Received
    August 5, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 14, 2008
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PHLEBOTOMIST WAS DRAWING BLOOD ON PT FROM A BD "BUTTERFLY" SAF-T-LOK WINGED COLLECTION SET. WHEN SHE ACTIVATED THE SAFETY DEVICE, THE TUBING BELOW BECAME DISCONNECTED AND BLOOD FLOWED OUT OF THE TUBING ONTO HER GLOVED HANDS. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: COLLECT BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET NONE JKA 7312104

    Patients

    Seq Age Sex Outcome Treatment
    1