MalfunctionGCD
URINARY CATHETER
Received Mar 26, 2015
Report 3005778470-2015-00003 · MDR key 4641731
Device
Product problems
- Folded
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. THERE WAS NO REPORTS OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. ADD'L PT/EVENT DETAILS HAVE BEEN REQUESTED. SHOULD ADD'L INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT UPON RECEIPT, THE URINARY CATHETER APPEARED TO HAVE BEEN "FOLDED." DURING URETHRA INTRODUCTION, THE URINARY CATHETER, 'FOLDED PRECISELY AT THE POINT OF INITIAL FOLDING' WHEN BEING INSERTED. NO PT INJURIES WERE REPORTED.