STANDARD OPERATING PROCEDURE FOR THE PREPARING AND MAINTAINING A by JYT808qI

VIEWS: 0 PAGES: 2

									                                     DEVICE DEFICIENCY FORM
                         **DO NOT SEND IDENTIFIBALE DATA WITH THIS FORM**
1. REPORT DETAILS
EudraCT number:
Clinical Investigation
name:
Centre number:
Country Deficiency
reported from:
Participant number:
Name/Identification of
device(s):
2. DEVICE DETAILS
Describe the nature of the device, it’s normal (label) applications and it’s applications in the Clinical
Investigation affected if different:


3. EVENT DETAILS
Date of deficiency (dd/mm/yyyy):

Description of deficiency:
Is this a deficiency with respect to identity, quality, durability, reliability, safety or performance of the device?
Please indicate:




Is the deficiency due to a malfunction, use error or inadequate labelling? Please Indicate:



Please provide any further details of the deficiency:




9. ACTION TAKEN (check all that are relevant to the SAE/SADE)
    No action taken                    Device discontinued due to this deficiency


11. ADDITIONAL INFORMATION




                                                CR012-T02v1.0

                                                  Page 1 of 2
12. INFORMATION SOURCE
Name, address and telephone
number of PI



Date of report (dd/mm/yyyy)

PI signature

         ALL REPORTS MUST BE SIGNED AND DATED BY THE PRINICPAL INVESTIGATOR.
                   PLEASE FAX ALL REPORTS TO ACCORD ON +44 (0)131 242 9447
13. ACCORD TRACKING (INTERNAL USE ONLY)
Report received by

Report received on
(dd/mm/yyyy)

Action taken


         N.B. If the deficiency caused a Serious Adverse Device Effect or an
         Unexpected Serious Adverse Device Effect, please report this separately to
         the ACCORD office according to SOP CR0012




                                        CR012-T02v1.0

                                          Page 2 of 2

								
To top