BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYRINGE DRNER

    MDR report key: 7439 · Received March 30, 1994

    Report

    Report Number
    35194-1994-09002
    Event Type
    Death
    Date Received
    March 30, 1994
    Date of Event
    March 16, 1994
    Report Date
    March 25, 1994
    Manufacturer
    GRASEBY MEDICAL LTD
    Product Code
    FIH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE WAS LOANED TO THE HOSPITAL FROM ANOTHER. UNIT WAS BEING USED ON A PATIENT AND AT SOME POINT ON 3/16/94, PATIENT DIED. THE CORONER'S OFFICE WAS INFORMED AND THEY CONFISCATED THE PUMP. NO OTHER DETAILS ARE AVAILABLE AS YET.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYRINGE DRNER SYRINGE FIH GRASEBY MEDICAL LTD MS16A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death