BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MS26 SYRINGE DRIVER

    MDR report key: 446381 · Received February 25, 2003

    Report

    Report Number
    9612511-2003-00001
    Event Type
    Malfunction
    Date Received
    February 25, 2003
    Date of Event
    January 27, 2003
    Report Date
    February 24, 2003
    Manufacturer
    GRASEBY MEDICAL LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OVERINFUSION, RATE SET AT 60MM OVER 24 HOURS. SYRINGE INFUSED SAME AMOUNT IN SIX HOURS. NO PATIENT INJURY, NO MEDICAL INTERVENTION. PATIENT OBSERVED TO BE SLEEPY AND COMFORTABLE AND RESPIRATORY RATE NORMAL. DEVICE UNDER EXAMINATION AT HOSPITAL. REQUESTED RETURN OF DEVICE. CUSTOMER WILL CALL WHEN THE DEVICE IS READY FOR RETURN TO GRASEBY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MS26 SYRINGE DRIVER SYRINGE DRIVER FRN GRASEBY MEDICAL LTD. MS26 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other