BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRASEBY PORTABLE SYRINGE DRIVER

    MDR report key: 104340 · Received July 7, 1997

    Report

    Report Number
    2183161-1997-00017
    Event Type
    Malfunction
    Date Received
    July 7, 1997
    Report Date
    March 6, 1997
    Manufacturer
    GRASEBY MEDICAL LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    USER REPORTED UNIT "RUNNING TOO FAST" (OVERINFUSING). THERE WAS NO REPORT OF PT INJURY OR MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRASEBY PORTABLE SYRINGE DRIVER SYRINGE DRIVER FRN GRASEBY MEDICAL LTD. MS16A 29722

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN