MalfunctionOFF
LOGICATH CATHETER
Received May 27, 2021 · Event occurred Apr 27, 2021
Report 3012307300-2021-05219 · MDR key 11897862
Device
Generic name
Central Venous Catheter Tray
Lot number
3838557
Product problems
- Difficult to Advance
- Difficult to Advance
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
CUSTOMER FACILITY PHONE NUMBER: (B)(6).
Description of Event or Problem
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CENTRAL VENOUS CATHETER WAS BEING USED FOR A FEMORAL VEIN PUNCTURE. THE GUIDEWIRE WOULD NOT PROGRESS AT THE DISTAL END. THERE WAS A DEFECT IN THE GROOVE THAT IS BELIEVED TO HAVE CAUSED THIS ISSUE. SUCCESS WAS ACHIEVED ONLY WITH THE 4TH PRODUCT. THERE WERE NO ADVERSE EVENTS REPORTED.
Additional Manufacturer Narrative
CORRECTED DATA: B1, CORRECTED DATA: CORRECTED DATA: B1-PRODUCT PROBLEM.