MalfunctionFEN
T-DOC
Received Jul 10, 2015 · Event occurred Jun 12, 2015
Report 9681424-2015-00004 · MDR key 4910095
Device
Generic name
Urodynamic Pressure Catheter
Manufacturer
Laborie Medical Technologies, Inc.Model number
TDOC-7FSCCatalog number
CAT878
Lot number
141136
Product problems
- Material Protrusion/Extrusion
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
CUSTOMER REPORTED THAT WHEN THEY REMOVED ONE CAT875 URODYNAMIC CATHETER FROM THE PACKAGE, THEY NOTICED A PIECE OF INTERNAL WIRE WAS STICKING OUT THROUGH THE CATHETER WALL. THE CATHETER WAS NOT USED ON A PT AND WILL BE RETURNED TO LABORIE FOR INVESTIGATION. IF IT HAD BEEN USED ON A PT, THERE WAS POTENTIAL THAT THE WIRE COULD HAVE MADE A TEAR IN THE URINARY TRACT.