FDA Adverse Event Death Summary report: N

MS26 SYRING DRIVER

MDR report key: 487873 · Received October 8, 2003

Report

Report Number
9612511-2003-00003
Event Type
Death
Date Received
October 8, 2003
Report Date
September 9, 2003
Manufacturer
GRASEBY MEDICAL LTD.
Product Code
FRN
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
AS
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

UNIT FORWARDED FROM POLICE SERVICE FOR TESTING. DEVICE WAS USED IN A NURSING HOME UP UNTIL AND INCLUDING THE DEATH OF PATIENT. PATIENT HAD BEEN PRESCRIBED MORPHINE BY ATTENDING GP TO BE ADMINISTERED VIA SYRINGE DRIVER. REPORTED PATIENT RECEIVED BOLUS OF MORPHINE AND ALLEGEDLY DIED AS A RESULT. REPORT SOURCED FROM POLICE SERVICE. DEVICE UNDER INVESTIGATION AND DEVICE IS UNLIKELY TO BE RETURNED TO MANUFACTURER FOR EVALUATION/TESTING AS THEY ARE NOW THE PROPERTY OF POLICE.

Devices

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

Patients

Seq Age Sex Outcome Treatment
1 UNKNOWN Death