BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEGUARD NON-CORING SAFETY INFUSION SET

    MDR report key: 1922091 · Received November 17, 2010

    Report

    Report Number
    2245270-2010-00018
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 11, 2010
    Report Date
    November 17, 2010
    Manufacturer
    VYGON (CHURCHILL MEDICAL SYSTEMS)
    Product Code
    FPA
    PMA / PMN Number
    K072375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THIS EVENT IS PENDING AND INCLUDES ADDITIONAL SIZES AS DESCRIBED BY THE CLINICIAN. THE PRODUCT CODES NAMED ARE CLG 2010 (LOT 1004175 AS NAMED ABOVE), CLG 2015 (LOT 802116 AND LOT 706117), CLG 2034 (LOT 912124). ONE SAMPLE WAS RETURNED BY THE FACILITY.

    Description of Event or Problem · 1

    THE CLINICIAN STATED THAT THE SAFETY FEATURE OF THE NEEDLE FAILED TO ENGAGE. THE CLINICIAN ALSO STATED THAT 8 MORE DEVICES OF THE SAME DEVICE IN DIFFERENT SIZES WERE OPENED TO TEST THE SAFETY FEATURE AND 4 OF THESE WERE DIFFICULT TO CLOSE THE HOUSING OVER THE NEEDLE, OR COULDN'T BE CLOSED. THE PRODUCT CODES AND THE LOT NUMBERS OF THE OTHER SIZES WERE ALSO LISTED IN THE REPORT. NO HARM WAS DONE TO THE PT OR CLINICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEGUARD NON-CORING SAFETY INFUSION SET NONE FPA VYGON (CHURCHILL MEDICAL SYSTEMS) CLG-2010 1004175

    Patients

    Seq Age Sex Outcome Treatment
    1